{"id":"amantadine","rwe":[],"_fda":{"id":"1497ce1d-a997-4828-a08d-3f93653a88d5","set_id":"0f70c79a-92a4-4a38-bbdd-900adc4c2e93","openfda":{"upc":["0342806716052"],"unii":["M6Q1EO9TD0"],"route":["ORAL"],"rxcui":["849389"],"spl_id":["1497ce1d-a997-4828-a08d-3f93653a88d5"],"brand_name":["amantadine hydrochloride"],"spl_set_id":["0f70c79a-92a4-4a38-bbdd-900adc4c2e93"],"package_ndc":["42806-716-11","42806-716-05"],"product_ndc":["42806-716"],"generic_name":["AMANTADINE HYDROCHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["AMANTADINE HYDROCHLORIDE"],"manufacturer_name":["EPIC PHARMA LLC"],"application_number":["ANDA214580"],"is_original_packager":[true]},"version":"8","warnings":["WARNINGS Deaths Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension (see OVERDOSAGE ). Deaths due to drug accumulation (overdosage) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of amantadine hydrochloride for their level of renal function [see DOSAGE AND ADMINISTRATION: Dosage of Impaired Renal Function and OVERDOSAGE ]. Suicide Attempts Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine, many of whom received short courses for influenza treatment or prophylaxis. The incidence of suicide attempts is not known and the pathophysiologic mechanism is not understood. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness. Amantadine can exacerbate mental problems in patients with a history of psychiatric disorders or substance abuse. Patients who attempt suicide may exhibit abnormal mental states which include disorientation, confusion, depression, personality changes, agitation, aggressive behavior, hallucinations, paranoia, other psychotic reactions, and somnolence or insomnia. Because of the possibility of serious adverse effects, caution should be observed when prescribing amantadine hydrochloride capsules to patients being treated with drugs having CNS effects, or for whom the potential risks outweigh the benefit of treatment. CNS Effects Patients with a history of epilepsy or other “seizures” should be observed closely for possible increased seizure activity. Patients receiving amantadine hydrochloride who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important. Other Patients with a history of congestive heart failure or peripheral edema should be followed closely as there are patients who developed congestive heart failure while receiving amantadine hydrochloride. Patients with Parkinson’s disease improving on amantadine hydrochloride capsules should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis. Because amantadine hydrochloride capsules has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma. Corneal Edema Corneal edema has been reported in patients taking amantadine. Symptoms include sudden onset of blurry vision, or progressive vision loss, with or without eye pain. Corneal involvement is usually bilateral. Onset can occur from a few weeks to several years after starting amantadine. Resolution of symptoms typically begins within weeks of amantadine cessation. However, corneal grafts have been required in some patients when the condition is not recognized. Permanent damage can occur if amantadine is continued. Ask patients if their vision has changed and obtain ophthalmologic examinations to rule out corneal edema should vision changes occur after initiation of therapy with amantadine hydrochloride capsules. If corneal edema occurs, taper and discontinue amantadine hydrochloride capsules [see Dosage and Administration ]."],"pregnancy":["Pregnancy The effect of amantadine on embryofetal and peri-postnatal development has not been adequately tested, that is, in studies conducted under Good Laboratory Practice (GLP) and according to current recommended methodology. However, in two non-GLP studies in rats in which females were dosed from 5 days prior to mating to Day 6 of gestation or on Days 7 to 14 of gestation, amantadine produced increases in embryonic death at an oral dose of 100 mg/kg (or 3 times the maximum recommended human dose on a mg/m 2 basis). In the non-GLP rat study in which females were dosed on Days 7 to 14 of gestation, there was a marked increase in severe visceral and skeletal malformations at oral doses of 50 and 100 mg/kg (or 1.5 and 3 times, respectively, the maximum recommended human dose on a mg/m 2 basis). The no-effect dose for teratogenicity was 37 mg/kg (equal to the maximum recommended human dose on a mg/m 2 basis). The safety margins reported may not accurately reflect the risk considering the questionable quality of the study on which they are based. There are no adequate and well-controlled studies in pregnant women. Human data regarding teratogenicity after maternal use of amantadine is scarce. Tetralogy of Fallot and tibial hemimelia (normal karyotype) occurred in an infant exposed to amantadine during the first trimester of pregnancy (100 mg P.O. for 7 days during the 6th and 7th week of gestation). Cardiovascular maldevelopment (single ventricle with pulmonary atresia) was associated with maternal exposure to amantadine (100 mg/d) administered during the first 2 weeks of pregnancy. Amantadine should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus."],"overdosage":["OVERDOSAGE Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension. Pulmonary edema and respiratory distress (including adult respiratory distress syndrome – ARDS) have been reported; renal dysfunction including increased BUN, decreased creatinine clearance and renal insufficiency can occur. Central nervous system effects that have been reported include insomnia, anxiety, agitation, aggressive behavior, hypertonia, hyperkinesia, ataxia, gait abnormality, tremor, confusion, disorientation, depersonalization, fear, delirium, hallucinations, psychotic reactions, lethargy, somnolence and coma. Seizures may be exacerbated in patients with prior history of seizure disorders. Hyperthermia has also been observed in cases where a drug overdose has occurred. There is no specific antidote for an overdose of amantadine. However, slowly administered intravenous physostigmine in 1 and 2 mg doses in an adult 2 at 1- to 2-hour intervals and 0.5 mg doses in a child 3 at 5- to 10-minute intervals up to a maximum of 2 mg/hour have been reported to be effective in the control of central nervous system toxicity caused by amantadine hydrochloride. For acute overdosing, general supportive measures should be employed along with immediate gastric lavage or induction of emesis. Fluids should be forced, and if necessary, given intravenously. The pH of the urine has been reported to influence the excretion rate of amantadine. Since the excretion rate of amantadine increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body. The blood pressure, pulse, respiration and temperature should be monitored. The patient should be observed for hyperactivity and convulsions; if required, sedation, and anticonvulsant therapy should be administered. The patient should be observed for the possible development of arrhythmias and hypotension; if required, appropriate antiarrhythmic and antihypotensive therapy should be given. Electrocardiographic monitoring may be required after ingestion, since malignant tachyarrhythmias can appear after overdose. Care should be exercised when administering adrenergic agents, such as isoproterenol, to patients with an amantadine overdose, since the dopaminergic activity of amantadine has been reported to induce malignant arrhythmias. The blood electrolytes, urine pH and urinary output should be monitored. If there is no record of recent voiding, catheterization should be done."],"references":["References 1 W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974-975, 1983. 2 D.F. Casey, N. Engl. J. Med. 298:516, 1978. 3 C.D. Berkowitz, J. Pediatr. 95:144, 1979. Manufactured by: Humanwell PuraCap Pharmaceutical Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 06-2025-00 PI-AMA-00"],"description":["DESCRIPTION Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C 10 H 18 NCl. It has the following structural formula: Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride, USP is available as 100 mg capsules for oral administration. Inactive ingredients: hydrogenated vegetable oil, lecithin, simethicone, soybean oil, white beeswax. The capsule shells contain: ferric oxide yellow, gelatin, glycerin, purified water, 1,4-sorbitan, mannitol, sorbitol, titanium dioxide, and light mineral oil. The imprinting ink contain: ammonia, black iron oxide, ethanol, n-butyl alcohol, propylene glycol, isopropyl alcohol. structure formula"],"precautions":["PRECAUTIONS Amantadine should not be discontinued abruptly in patients with Parkinson’s disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of amantadine should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech. Neuroleptic Malignant Syndrome (NMS) Sporadic cases of possible Neuroleptic Malignant Syndrome (NMS) have been reported in association with dose reduction or withdrawal of amantadine therapy. Therefore, patients should be observed carefully when the dosage of amantadine is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia; neurologic findings including muscle rigidity, involuntary movements, altered consciousness; mental status changes; other disturbances such as autonomic dysfunction, tachycardia, tachypnea, hyper- or hypotension; laboratory findings such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin. The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring, and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene are often used in the treatment of NMS, however, their effectiveness has not been demonstrated in controlled studies. Renal Disease Because amantadine is mainly excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine should be reduced in patients with renal impairment and in individuals who are 65 years of age or older (see DOSAGE AND ADMINISTRATION: Dosage for Impaired Renal Function ). Liver Disease Care should be exercised when administering amantadine to patients with liver disease. Rare instances of reversible elevation of liver enzymes have been reported in patients receiving amantadine, though a specific relationship between the drug and such changes has not been established. Impulse Control/Compulsive Behaviors Postmarketing reports suggest that patients treated with anti-Parkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. Patients may be unable to control these urges while taking one or more of the medications that are generally used for the treatment of Parkinson’s disease and that increase central dopaminergic tone, including amantadine hydrochloride. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with amantadine hydrochloride. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking amantadine hydrochloride. Melanoma Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using amantadine for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists). Other The dose of amantadine may need careful adjustment in patients with congestive heart failure, peripheral edema, or orthostatic hypotension. Care should be exercised when administering amantadine to patients with a history of recurrent eczematoid rash, or to patients with psychosis or severe psychoneurosis not controlled by chemotherapeutic agents. Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Amantadine has not been shown to prevent such complications. Information for Patients Patients should be advised of the following information: Blurry vision, eye pain, loss of vision and/or impaired mental acuity may occur. Gradually increase physical activity as the symptoms of Parkinson’s disease improve. Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness and orthostatic hypotension. Avoid getting up suddenly from a sitting or lying position. If dizziness or lightheadedness occurs, notify physician. Notify physician if mood/mental changes, swelling of extremities, difficulty urinating and/or shortness of breath occur. Do not take more medication than prescribed because of the risk of overdose. If there is no improvement in a few days, or if medication appears less effective after a few weeks, discuss with a physician. Consult physician before discontinuing medication. Seek medical attention immediately if it is suspected that an overdose of medication has been taken. Drug Interactions Careful observation is required when amantadine is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine. Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson’s disease, however, it is not known if other phenothiazines produce a similar response. Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson’s disease 1 . It is not known which of the components of triamterene and hydrochlorothiazide capsules contributed to the observation or if related drugs produce a similar response. Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%. The concurrent use of amantadine with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine. Carcinogenesis and Mutagenesis Long-term in vivo animal studies designed to evaluate the carcinogenic potential of amantadine have not been performed. In several in vitro assays for gene mutation, amantadine did not increase the number of spontaneously observed mutations in four strains of Salmonella typhimurium (Ames Test) or in a mammalian cell line (Chinese Hamster Ovary cells) when incubations were performed either with or without a liver metabolic activation extract. Further, there was no evidence of chromosome damage observed in an in vitro test using freshly derived and stimulated human peripheral blood lymphocytes (with and without metabolic activation) or in an in vivo mouse bone marrow micronucleus test (140 to 550 mg/kg; estimated human equivalent doses of 11.7 to 45.8 mg/kg based on body surface area conversion). Impairment of Fertility The effect of amantadine on fertility has not been adequately tested, that is, in a study conducted under Good Laboratory Practice (GLP) and according to current recommended methodology. In a three litter, non-GLP, reproduction study in rats, amantadine at a dose of 32 mg/kg/day (equal to the maximum recommended human dose on a mg/m 2 basis) administered to both males and females slightly impaired fertility. There were no effects on fertility at a dose level of 10 mg/kg/day (or 0.3 times the maximum recommended human dose on a mg/m 2 basis); intermediate doses were not tested. Failed fertility has been reported during human in vitro fertilization (IVF) when the sperm donor ingested amantadine 2 weeks prior to, and during the IVF cycle. Pregnancy The effect of amantadine on embryofetal and peri-postnatal development has not been adequately tested, that is, in studies conducted under Good Laboratory Practice (GLP) and according to current recommended methodology. However, in two non-GLP studies in rats in which females were dosed from 5 days prior to mating to Day 6 of gestation or on Days 7 to 14 of gestation, amantadine produced increases in embryonic death at an oral dose of 100 mg/kg (or 3 times the maximum recommended human dose on a mg/m 2 basis). In the non-GLP rat study in which females were dosed on Days 7 to 14 of gestation, there was a marked increase in severe visceral and skeletal malformations at oral doses of 50 and 100 mg/kg (or 1.5 and 3 times, respectively, the maximum recommended human dose on a mg/m 2 basis). The no-effect dose for teratogenicity was 37 mg/kg (equal to the maximum recommended human dose on a mg/m 2 basis). The safety margins reported may not accurately reflect the risk considering the questionable quality of the study on which they are based. There are no adequate and well-controlled studies in pregnant women. Human data regarding teratogenicity after maternal use of amantadine is scarce. Tetralogy of Fallot and tibial hemimelia (normal karyotype) occurred in an infant exposed to amantadine during the first trimester of pregnancy (100 mg P.O. for 7 days during the 6th and 7th week of gestation). Cardiovascular maldevelopment (single ventricle with pulmonary atresia) was associated with maternal exposure to amantadine (100 mg/d) administered during the first 2 weeks of pregnancy. Amantadine should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. Nursing Mothers Amantadine is excreted in human milk. Use is not recommended in nursing mothers. Pediatric Use The safety and efficacy of amantadine in newborn infants and infants below the age of 1 year have not been established. Use in the Elderly Because amantadine is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine should be reduced in patients with renal impairment and in individuals who are 65 years of age or older. The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, or orthostatic hypotension (see DOSAGE AND ADMINISTRATION )."],"how_supplied":["HOW SUPPLIED Amantadine hydrochloride capsules, USP 100 mg are soft gelatin capsule, opaque yellow oblong shape, which is imprinted with “P19” in Black ink. Capsules are free of surface stickiness and leaking. The fill materials are practically off-white to light yellow suspension and supplied as follows: NDC 42806-716-11 bottles of 10 capsules NDC 42806-716-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP."],"pediatric_use":["Pediatric Use The safety and efficacy of amantadine in newborn infants and infants below the age of 1 year have not been established."],"effective_time":"20250606","nursing_mothers":["Nursing Mothers Amantadine is excreted in human milk. Use is not recommended in nursing mothers."],"pharmacodynamics":["Pharmacodynamics Mechanism of Action Antiviral The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein. In certain cases, amantadine is also known to prevent virus assembly during virus replication. It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine. Antiviral Activity Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no activity against influenza B virus isolates. A quantitative relationship between the in vitro susceptibility of influenza A virus to amantadine and the clinical response to therapy has not been established in man. Sensitivity test results, expressed as the concentration of amantadine required to inhibit by 50% the growth of virus (ED 50 ) in tissue culture vary greatly (from 0.1 mcg/mL to 25.0 mcg/mL) depending upon the assay protocol used, size of virus inoculum, isolates of influenza A virus strains tested, and the cell type used. Host cells in tissue culture readily tolerated amantadine up to a concentration of 100 mcg/mL. Drug Resistance Influenza A variants with reduced in vitro sensitivity to amantadine have been isolated from epidemic strains in areas where adamantane derivatives are being used. Influenza viruses with reduced in vitro sensitivity have been shown to be transmissible and to cause typical influenza illness. The quantitative relationship between the in vitro sensitivity of influenza A variants to amantadine and the clinical response to therapy has not been established. Mechanism of Action Parkinson’s Disease The mechanism of action of amantadine in the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions is not known. Data from earlier animal studies suggest that amantadine may have direct and indirect effects on dopamine neurons. More recent studies have demonstrated that amantadine is a weak, non-competitive NMDA receptor antagonist (Ki = 10 µM). Although amantadine has not been shown to possess direct anticholinergic activity in animal studies, clinically, it exhibits anticholinergic-like side effects such as dry mouth, urinary retention, and constipation."],"pharmacokinetics":["Pharmacokinetics Amantadine is well absorbed orally. Maximum plasma concentrations are directly related to dose for doses up to 200 mg/day. Doses above 200 mg/day may result in a greater than proportional increase in maximum plasma concentrations. It is primarily excreted unchanged in the urine by glomerular filtration and tubular secretion. Eight metabolites of amantadine have been identified in human urine. One metabolite, an N-acetylated compound, was quantified in human urine and accounted for 5 to 15% of the administered dose. Plasma acetylamantadine accounted for up to 80% of the concurrent amantadine plasma concentration in 5 of 12 healthy volunteers following the ingestion of a 200 mg dose of amantadine. Acetylamantadine was not detected in the plasma of the remaining seven volunteers. The contribution of this metabolite to efficacy or toxicity is not known. There appears to be a relationship between plasma amantadine concentrations and toxicity. As concentration increases, toxicity seems to be more prevalent, however, absolute values of amantadine concentrations associated with adverse effects have not been fully defined. Amantadine pharmacokinetics were determined in 24 normal adult male volunteers after the oral administration of a single amantadine hydrochloride 100 mg soft gel capsule. The mean ± SD maximum plasma concentration was 0.22 ± 0.03 mcg/mL (range: 0.18 to 0.32 mcg/mL). The time to peak concentration was 3.3 ± 1.5 hours (range: 1.5 to 8.0 hours). The apparent oral clearance was 0.28 ± 0.11 L/hr/kg (range: 0.14 to 0.62 L/hr/kg). The half-life was 17 ± 4 hours (range: 10 to 25 hours). Across other studies, amantadine plasma half-life has averaged 16 ± 6 hours (range: 9 to 31 hours) in 19 healthy volunteers. After oral administration of a single dose of 100 mg amantadine syrup to five healthy volunteers, the mean ± SD maximum plasma concentration C max was 0.24 ± 0.04 mcg/mL and ranged from 0.18 to 0.28 mcg/mL. After 15 days of amantadine 100 mg b.i.d., the C max was 0.47 ± 0.11 mcg/mL in four of the five volunteers. The administration of amantadine tablets as a 200 mg single dose to 6 healthy subjects resulted in a C max of 0.51 ± 0.14 mcg/mL. Across studies, the time to C max (T max ) averaged about 2 to 4 hours. Plasma amantadine clearance ranged from 0.2 to 0.3 L/hr/kg after the administration of 5 mg to 25 mg intravenous doses of amantadine to 15 healthy volunteers. In six healthy volunteers, the ratio of amantadine renal clearance to apparent oral plasma clearance was 0.79 ± 0.17 (mean ± SD). The volume of distribution determined after the intravenous administration of amantadine to 15 healthy subjects was 3 to 8 L/kg, suggesting tissue binding. Amantadine, after single oral 200 mg doses to 6 healthy young subjects and to 6 healthy elderly subjects has been found in nasal mucus at mean ± SD concentrations of 0.15 ± 0.16, 0.28 ± 0.26, and 0.39 ± 0.34 mcg/g at 1, 4, and 8 hours after dosing, respectively. These concentrations represented 31 ± 33%, 59 ± 61% ,and 95 ± 86% of the corresponding plasma amantadine concentrations. Amantadine is approximately 67% bound to plasma proteins over a concentration range of 0.1 to 2.0 mcg/mL. Following the administration of amantadine 100 mg as a single dose, the mean ± SD red blood cell to plasma ratio ranged from 2.7 ± 0.5 in 6 healthy subjects to 1.4 ± 0.2 in 8 patients with renal insufficiency. The apparent oral plasma clearance of amantadine is reduced and the plasma half-life and plasma concentrations are increased in healthy elderly individuals age 60 and older. After single dose administration of 25 to 75 mg to 7 healthy, elderly male volunteers, the apparent plasma clearance of amantadine was 0.10 ± 0.04 L/hr/kg (range 0.06 to 0.17 L/hr/kg) and the half-life was 29 ± 7 hours (range 20 to 41 hours). Whether these changes are due to decline in renal function or other age related factors is not known. In a study of young healthy subjects (n=20), mean renal clearance of amantadine, normalized for body mass index, was 1.5 fold higher in males compared to females (p<0.032). Compared with otherwise healthy adult individuals, the clearance of amantadine is significantly reduced in adult patients with renal insufficiency. The elimination half-life increases two to three fold or greater when creatinine clearance is less than 40 mL/min/1.73 m 2 and averages eight days in patients on chronic maintenance hemodialysis. Amantadine is removed in negligible amounts by hemodialysis. The pH of the urine has been reported to influence the excretion rate of amantadine. Since the excretion rate of amantadine increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body."],"adverse_reactions":["ADVERSE REACTIONS The adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy. Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation (see WARNINGS ). Other adverse reactions reported during postmarketing experience with amantadine usage include: Nervous System/Psychiatric coma, stupor, delirium, hypokinesia, hypertonia, delusions, aggressive behavior, paranoid reaction, manic reaction, involuntary muscle contractions, gait abnormalities, paresthesia, EEG changes, and tremor. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech; Cardiovascular cardiac arrest, arrhythmias including malignant arrhythmias, hypotension, and tachycardia; Respiratory acute respiratory failure, pulmonary edema, and tachypnea; Gastrointestinal dysphagia; Hematologic leukocytosis, agranulocytosis; Special Senses Keratitis, mydriasis, and corneal edema; Skin and Appendages pruritus and diaphoresis; Miscellaneous neuroleptic malignant syndrome (see WARNINGS ), allergic reactions including anaphylactic reactions, edema, fever. Laboratory Test elevated: CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, GGT, SGOT, and SGPT."],"contraindications":["CONTRAINDICATIONS Amantadine hydrochloride capsules, USP are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride capsules, USP."],"drug_interactions":["Drug Interactions Careful observation is required when amantadine is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine. Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson’s disease, however, it is not known if other phenothiazines produce a similar response. Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson’s disease 1 . It is not known which of the components of triamterene and hydrochlorothiazide capsules contributed to the observation or if related drugs produce a similar response. Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%. The concurrent use of amantadine with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pharmacodynamics Mechanism of Action Antiviral The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein. In certain cases, amantadine is also known to prevent virus assembly during virus replication. It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine. Antiviral Activity Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no activity against influenza B virus isolates. A quantitative relationship between the in vitro susceptibility of influenza A virus to amantadine and the clinical response to therapy has not been established in man. Sensitivity test results, expressed as the concentration of amantadine required to inhibit by 50% the growth of virus (ED 50 ) in tissue culture vary greatly (from 0.1 mcg/mL to 25.0 mcg/mL) depending upon the assay protocol used, size of virus inoculum, isolates of influenza A virus strains tested, and the cell type used. Host cells in tissue culture readily tolerated amantadine up to a concentration of 100 mcg/mL. Drug Resistance Influenza A variants with reduced in vitro sensitivity to amantadine have been isolated from epidemic strains in areas where adamantane derivatives are being used. Influenza viruses with reduced in vitro sensitivity have been shown to be transmissible and to cause typical influenza illness. The quantitative relationship between the in vitro sensitivity of influenza A variants to amantadine and the clinical response to therapy has not been established. Mechanism of Action Parkinson’s Disease The mechanism of action of amantadine in the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions is not known. Data from earlier animal studies suggest that amantadine may have direct and indirect effects on dopamine neurons. More recent studies have demonstrated that amantadine is a weak, non-competitive NMDA receptor antagonist (Ki = 10 µM). Although amantadine has not been shown to possess direct anticholinergic activity in animal studies, clinically, it exhibits anticholinergic-like side effects such as dry mouth, urinary retention, and constipation. Pharmacokinetics Amantadine is well absorbed orally. Maximum plasma concentrations are directly related to dose for doses up to 200 mg/day. Doses above 200 mg/day may result in a greater than proportional increase in maximum plasma concentrations. It is primarily excreted unchanged in the urine by glomerular filtration and tubular secretion. Eight metabolites of amantadine have been identified in human urine. One metabolite, an N-acetylated compound, was quantified in human urine and accounted for 5 to 15% of the administered dose. Plasma acetylamantadine accounted for up to 80% of the concurrent amantadine plasma concentration in 5 of 12 healthy volunteers following the ingestion of a 200 mg dose of amantadine. Acetylamantadine was not detected in the plasma of the remaining seven volunteers. The contribution of this metabolite to efficacy or toxicity is not known. There appears to be a relationship between plasma amantadine concentrations and toxicity. As concentration increases, toxicity seems to be more prevalent, however, absolute values of amantadine concentrations associated with adverse effects have not been fully defined. Amantadine pharmacokinetics were determined in 24 normal adult male volunteers after the oral administration of a single amantadine hydrochloride 100 mg soft gel capsule. The mean ± SD maximum plasma concentration was 0.22 ± 0.03 mcg/mL (range: 0.18 to 0.32 mcg/mL). The time to peak concentration was 3.3 ± 1.5 hours (range: 1.5 to 8.0 hours). The apparent oral clearance was 0.28 ± 0.11 L/hr/kg (range: 0.14 to 0.62 L/hr/kg). The half-life was 17 ± 4 hours (range: 10 to 25 hours). Across other studies, amantadine plasma half-life has averaged 16 ± 6 hours (range: 9 to 31 hours) in 19 healthy volunteers. After oral administration of a single dose of 100 mg amantadine syrup to five healthy volunteers, the mean ± SD maximum plasma concentration C max was 0.24 ± 0.04 mcg/mL and ranged from 0.18 to 0.28 mcg/mL. After 15 days of amantadine 100 mg b.i.d., the C max was 0.47 ± 0.11 mcg/mL in four of the five volunteers. The administration of amantadine tablets as a 200 mg single dose to 6 healthy subjects resulted in a C max of 0.51 ± 0.14 mcg/mL. Across studies, the time to C max (T max ) averaged about 2 to 4 hours. Plasma amantadine clearance ranged from 0.2 to 0.3 L/hr/kg after the administration of 5 mg to 25 mg intravenous doses of amantadine to 15 healthy volunteers. In six healthy volunteers, the ratio of amantadine renal clearance to apparent oral plasma clearance was 0.79 ± 0.17 (mean ± SD). The volume of distribution determined after the intravenous administration of amantadine to 15 healthy subjects was 3 to 8 L/kg, suggesting tissue binding. Amantadine, after single oral 200 mg doses to 6 healthy young subjects and to 6 healthy elderly subjects has been found in nasal mucus at mean ± SD concentrations of 0.15 ± 0.16, 0.28 ± 0.26, and 0.39 ± 0.34 mcg/g at 1, 4, and 8 hours after dosing, respectively. These concentrations represented 31 ± 33%, 59 ± 61% ,and 95 ± 86% of the corresponding plasma amantadine concentrations. Amantadine is approximately 67% bound to plasma proteins over a concentration range of 0.1 to 2.0 mcg/mL. Following the administration of amantadine 100 mg as a single dose, the mean ± SD red blood cell to plasma ratio ranged from 2.7 ± 0.5 in 6 healthy subjects to 1.4 ± 0.2 in 8 patients with renal insufficiency. The apparent oral plasma clearance of amantadine is reduced and the plasma half-life and plasma concentrations are increased in healthy elderly individuals age 60 and older. After single dose administration of 25 to 75 mg to 7 healthy, elderly male volunteers, the apparent plasma clearance of amantadine was 0.10 ± 0.04 L/hr/kg (range 0.06 to 0.17 L/hr/kg) and the half-life was 29 ± 7 hours (range 20 to 41 hours). Whether these changes are due to decline in renal function or other age related factors is not known. In a study of young healthy subjects (n=20), mean renal clearance of amantadine, normalized for body mass index, was 1.5 fold higher in males compared to females (p<0.032). Compared with otherwise healthy adult individuals, the clearance of amantadine is significantly reduced in adult patients with renal insufficiency. The elimination half-life increases two to three fold or greater when creatinine clearance is less than 40 mL/min/1.73 m 2 and averages eight days in patients on chronic maintenance hemodialysis. Amantadine is removed in negligible amounts by hemodialysis. The pH of the urine has been reported to influence the excretion rate of amantadine. Since the excretion rate of amantadine increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body."],"indications_and_usage":["INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules, USP will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules, USP are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules, USP. • Amantadine hydrochloride capsules, USP are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules, USP. Parkinson’s Disease/Syndrome Amantadine hydrochloride capsules, USP are indicated in the treatment of idiopathic Parkinson’s disease (Paralysis Agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson’s disease, amantadine is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established. Drug-Induced Extrapyramidal Reactions Amantadine hydrochloride, USP is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with amantadine when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs."],"information_for_patients":["Information for Patients Patients should be advised of the following information: Blurry vision, eye pain, loss of vision and/or impaired mental acuity may occur. Gradually increase physical activity as the symptoms of Parkinson’s disease improve. Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness and orthostatic hypotension. Avoid getting up suddenly from a sitting or lying position. If dizziness or lightheadedness occurs, notify physician. Notify physician if mood/mental changes, swelling of extremities, difficulty urinating and/or shortness of breath occur. Do not take more medication than prescribed because of the risk of overdose. If there is no improvement in a few days, or if medication appears less effective after a few weeks, discuss with a physician. Consult physician before discontinuing medication. Seek medical attention immediately if it is suspected that an overdose of medication has been taken."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for Impaired Renal Function )."],"spl_product_data_elements":["amantadine hydrochloride amantadine hydrochloride AMANTADINE HYDROCHLORIDE AMANTADINE HYDROGENATED COTTONSEED OIL LECITHIN, SOYBEAN SILICON DIOXIDE SOYBEAN OIL WHITE WAX AMMONIA FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW GELATIN, UNSPECIFIED GLYCERIN MANNITOL BUTYL ALCOHOL PROPYLENE GLYCOL WATER ISOPROPYL ALCOHOL 1,4-SORBITAN SORBITOL TITANIUM DIOXIDE LIGHT MINERAL OIL Opaque Oblong P19"],"use_in_specific_populations":["Use in the Elderly Because amantadine is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine should be reduced in patients with renal impairment and in individuals who are 65 years of age or older. The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, or orthostatic hypotension (see DOSAGE AND ADMINISTRATION )."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 500ct amantadine-100mg-500ct.jpg"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis and Mutagenesis Long-term in vivo animal studies designed to evaluate the carcinogenic potential of amantadine have not been performed. In several in vitro assays for gene mutation, amantadine did not increase the number of spontaneously observed mutations in four strains of Salmonella typhimurium (Ames Test) or in a mammalian cell line (Chinese Hamster Ovary cells) when incubations were performed either with or without a liver metabolic activation extract. Further, there was no evidence of chromosome damage observed in an in vitro test using freshly derived and stimulated human peripheral blood lymphocytes (with and without metabolic activation) or in an in vivo mouse bone marrow micronucleus test (140 to 550 mg/kg; estimated human equivalent doses of 11.7 to 45.8 mg/kg based on body surface area conversion)."]},"tags":[{"label":"Influenza A M2 Protein Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sigma non-opioid intracellular receptor 1","category":"target"},{"label":"SIGMAR1","category":"gene"},{"label":"GRIN1","category":"gene"},{"label":"GRIN2A","category":"gene"},{"label":"N04BB01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Solution","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Arteriosclerotic Parkinsonism","category":"indication"},{"label":"Extrapyramidal disease","category":"indication"},{"label":"Influenza A Prevention","category":"indication"},{"label":"Influenza due to Influenza A virus","category":"indication"},{"label":"Parkinson's disease","category":"indication"},{"label":"Parkinsonism","category":"indication"},{"label":"Endo Pharms","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Analgesics","category":"pharmacology"},{"label":"Analgesics, Non-Narcotic","category":"pharmacology"},{"label":"Anti-Dyskinesia Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiparkinson Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Dopamine Agents","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":1041.201,"date":"","count":580,"signal":"Hallucination","source":"DrugCentral FAERS","actionTaken":"Reported 580 times (LLR=1041)"},{"llr":1035.64,"date":"","count":467,"signal":"Dyskinesia","source":"DrugCentral FAERS","actionTaken":"Reported 467 times (LLR=1036)"},{"llr":577.247,"date":"","count":159,"signal":"On and off phenomenon","source":"DrugCentral FAERS","actionTaken":"Reported 159 times (LLR=577)"},{"llr":540.173,"date":"","count":263,"signal":"Hallucination, visual","source":"DrugCentral FAERS","actionTaken":"Reported 263 times (LLR=540)"},{"llr":406.612,"date":"","count":742,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 742 times (LLR=407)"},{"llr":395.279,"date":"","count":109,"signal":"Freezing phenomenon","source":"DrugCentral FAERS","actionTaken":"Reported 109 times (LLR=395)"},{"llr":349.538,"date":"","count":232,"signal":"Multiple sclerosis relapse","source":"DrugCentral FAERS","actionTaken":"Reported 232 times (LLR=350)"},{"llr":291.662,"date":"","count":369,"signal":"Tremor","source":"DrugCentral FAERS","actionTaken":"Reported 369 times (LLR=292)"},{"llr":270.669,"date":"","count":80,"signal":"Stoma site discharge","source":"DrugCentral FAERS","actionTaken":"Reported 80 times (LLR=271)"},{"llr":262.462,"date":"","count":105,"signal":"Bradykinesia","source":"DrugCentral FAERS","actionTaken":"Reported 105 times (LLR=262)"},{"llr":260.181,"date":"","count":392,"signal":"Gait disturbance","source":"DrugCentral FAERS","actionTaken":"Reported 392 times (LLR=260)"},{"llr":236.431,"date":"","count":54,"signal":"Dopamine dysregulation syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=236)"},{"llr":235.92,"date":"","count":128,"signal":"Muscle rigidity","source":"DrugCentral FAERS","actionTaken":"Reported 128 times (LLR=236)"},{"llr":225.972,"date":"","count":139,"signal":"Multiple sclerosis","source":"DrugCentral FAERS","actionTaken":"Reported 139 times (LLR=226)"},{"llr":213.344,"date":"","count":133,"signal":"Neuroleptic malignant syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 133 times (LLR=213)"}],"drugInteractions":[{"url":"/drug/bupropion","drug":"bupropion","action":"Monitor closely","effect":"May interact with Bupropion","source":"DrugCentral","drugSlug":"bupropion"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Dizziness/lightheadedness","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Insomnia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Depression","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Congestive heart failure","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Convulsion","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Anxiety and irritability","drugRate":"reported","severity":"common"},{"effect":"Psychosis","drugRate":"reported","severity":"serious"},{"effect":"Leukopenia","drugRate":"reported","severity":"serious"},{"effect":"Hallucinations","drugRate":"reported","severity":"serious"},{"effect":"Urinary retention","drugRate":"reported","severity":"serious"},{"effect":"Neutropenia","drugRate":"reported","severity":"serious"},{"effect":"Confusion","drugRate":"reported","severity":"serious"},{"effect":"Dyspnea","drugRate":"reported","severity":"serious"},{"effect":"Eczematoid dermatitis","drugRate":"reported","severity":"serious"},{"effect":"Anorexia","drugRate":"reported","severity":"common"},{"effect":"Skin rash","drugRate":"reported","severity":"common"},{"effect":"Oculogyric episodes","drugRate":"reported","severity":"serious"},{"effect":"Dry mouth","drugRate":"reported","severity":"common"},{"effect":"Vomiting","drugRate":"reported","severity":"serious"},{"effect":"Suicidal attempt","drugRate":"reported","severity":"serious"},{"effect":"Constipation","drugRate":"reported","severity":"common"},{"effect":"Weakness","drugRate":"reported","severity":"common"},{"effect":"Suicide","drugRate":"reported","severity":"serious"},{"effect":"Ataxia","drugRate":"reported","severity":"serious"},{"effect":"Slurred speech","drugRate":"reported","severity":"serious"},{"effect":"Suicidal ideation","drugRate":"reported","severity":"serious"},{"effect":"Livedo reticularis","drugRate":"reported","severity":"serious"},{"effect":"Euphoria","drugRate":"reported","severity":"common"},{"effect":"Peripheral edema","drugRate":"reported","severity":"common"},{"effect":"Thinking abnormality","drugRate":"reported","severity":"common"},{"effect":"Orthostatic hypotension","drugRate":"reported","severity":"serious"},{"effect":"Amnesia","drugRate":"reported","severity":"serious"},{"effect":"Headache","drugRate":"reported","severity":"common"},{"effect":"Hyperkinesia","drugRate":"reported","severity":"common"},{"effect":"Somnolence","drugRate":"reported","severity":"common"},{"effect":"Hypertension","drugRate":"reported","severity":"serious"},{"effect":"Nervousness","drugRate":"reported","severity":"common"},{"effect":"Decreased libido","drugRate":"reported","severity":"common"},{"effect":"Dream abnormality","drugRate":"reported","severity":"common"},{"effect":"Visual disturbance","drugRate":"reported","severity":"serious"},{"effect":"Agitation","drugRate":"reported","severity":"serious"},{"effect":"Punctate subepithelial or other corneal opacity","drugRate":"reported","severity":"serious"},{"effect":"Dry nose","drugRate":"reported","severity":"common"},{"effect":"Corneal edema","drugRate":"reported","severity":"serious"},{"effect":"Diarrhea","drugRate":"reported","severity":"common"},{"effect":"Decreased visual acuity","drugRate":"reported","severity":"serious"},{"effect":"Fatigue","drugRate":"reported","severity":"common"},{"effect":"Sensitivity to light","drugRate":"reported","severity":"common"},{"effect":"Optic nerve palsy","drugRate":"reported","severity":"serious"}],"contraindications":["Angle-closure glaucoma","Chronic heart failure","Eczema","Edema","Epilepsy","Kidney disease","Malignant melanoma","Orthostatic hypotension","Psychiatric Disturbance","Psychotic disorder","Substance abuse","Suicidal thoughts"],"specialPopulations":{"Pregnancy":"The effect of amantadine on embryofetal and peri-postnatal development has not been adequately tested. However, in two non-GLP studies in rats, amantadine hydrochloride produced increases in embryonic death at an oral dose of 100 mg/kg.","Geriatric use":"Because amantadine is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine hydrochloride should be reduced in patients with renal impairment and in individuals who are 65 years of age or older.","Paediatric use":"The safety and efficacy of amantadine hydrochloride in newborn infants and infants below the age of 1 year have not been established.","Renal impairment":"The dose of amantadine hydrochloride should be reduced in patients with renal impairment."}},"trials":[],"aliases":[],"company":"Endo","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1925/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$70","description":"AMANTADINE 100 MG CAPSULE","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMANTADINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:17:54.764112+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Amantadine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:18:03.076870+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:18:01.370520+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMANTADINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:18:01.904876+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:17:53.586664+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:17:53.586697+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL660/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:02.724679+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA214580","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:17:53.586702+00:00"}},"allNames":"gocovri","offLabel":[],"synonyms":["amantadine","adamantamine","adamantanamine","adamantylamine","amantadine hydrochloride","amantidine","adamantamine fumarate","amantadine HCl","amantadine sulfate"],"timeline":[{"date":"1968-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ENDO PHARMS to Endo Pharms"},{"date":"1968-02-14","type":"positive","source":"DrugCentral","milestone":"FDA approval (Endo Pharms)"},{"date":"2017-08-24","type":"positive","source":"FDA Orange Book","milestone":"Gocovri approved — EQ 68.5MG BASE"},{"date":"2020-04-22","type":"positive","source":"FDA Orange Book","milestone":"Osmolex Er approved — EQ 161MG BASE"},{"date":"2021-08-20","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 26 manufacturers approved"}],"aiSummary":"Gocovri (amantadine) is a small molecule modality developed by Endo Pharms, targeting the Sigma non-opioid intracellular receptor 1. Originally approved in 1968, it is an influenza A M2 protein inhibitor with a 90% bioavailability and a half-life of 16 hours. Gocovri is used to treat various conditions, including Parkinson's disease, Parkinsonism, and influenza A, and is available as a generic medication due to its off-patent status. With over 30 generic manufacturers, Gocovri is widely accessible. As an off-patent medication, its commercial status is generic.","brandName":"Gocovri","ecosystem":[{"indication":"Arteriosclerotic Parkinsonism","otherDrugs":[{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"biperiden","slug":"biperiden","company":"Abbvie"},{"name":"procyclidine","slug":"procyclidine","company":""},{"name":"trihexyphenidyl","slug":"trihexyphenidyl","company":""}],"globalPrevalence":null},{"indication":"Extrapyramidal disease","otherDrugs":[{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"biperiden","slug":"biperiden","company":"Abbvie"},{"name":"procyclidine","slug":"procyclidine","company":""},{"name":"trihexyphenidyl","slug":"trihexyphenidyl","company":""}],"globalPrevalence":null},{"indication":"Influenza A Prevention","otherDrugs":[{"name":"rimantadine","slug":"rimantadine","company":"Caraco"}],"globalPrevalence":null},{"indication":"Influenza due to Influenza A virus","otherDrugs":[{"name":"rimantadine","slug":"rimantadine","company":"Caraco"}],"globalPrevalence":null},{"indication":"Parkinson's disease","otherDrugs":[{"name":"apomorphine","slug":"apomorphine","company":"Us Worldmeds"},{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"biperiden","slug":"biperiden","company":"Abbvie"},{"name":"bromocriptine","slug":"bromocriptine","company":"Us Pharms Holdings I"}],"globalPrevalence":8500000},{"indication":"Parkinsonism","otherDrugs":[{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"biperiden","slug":"biperiden","company":"Abbvie"},{"name":"carbidopa","slug":"carbidopa","company":"Merck Sharp Dohme"},{"name":"levodopa","slug":"levodopa","company":""}],"globalPrevalence":null},{"indication":"Postencephalitic parkinsonism","otherDrugs":[{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"biperiden","slug":"biperiden","company":"Abbvie"},{"name":"bromocriptine","slug":"bromocriptine","company":"Us Pharms Holdings I"},{"name":"carbidopa","slug":"carbidopa","company":"Merck Sharp Dohme"}],"globalPrevalence":null}],"mechanism":{"target":"Sigma non-opioid intracellular receptor 1","novelty":"Follow-on","targets":[{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"GRIN1","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 1"},{"gene":"GRIN2A","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2A"},{"gene":"GRIN2B","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2B"},{"gene":"GRIN2C","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2C"},{"gene":"GRIN2D","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2D"},{"gene":"GRIN3A","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 3A"},{"gene":"GRIN3B","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 3B"},{"gene":"SLC47A1","source":"DrugCentral","target":"Multidrug and toxin extrusion protein 1","protein":"Multidrug and toxin extrusion protein 1"}],"moaClass":"M2 Protein Inhibitors","modality":"Small Molecule","drugClass":"Influenza A M2 Protein Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Gocovri (amantadine) acts as a non-competitive antagonist of the M2 ion channel, inhibiting the proton influx and subsequent uncoating of the influenza A virus, thereby preventing viral replication and infection."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Amantadine","title":"Amantadine","extract":"Amantadine, sold under the brand name Gocovri among others, is a medication used to treat dyskinesia associated with parkinsonism and influenza caused by type A influenzavirus, though its use for the latter is no longer recommended because of widespread drug resistance. It is also used for a variety of other conditions. The drug is taken by mouth.","wiki_history":"==History==\n===Influenza A===\nAntiviral properties were first reported in 1963 at the University of Illinois Hospital in Chicago. In this amantadine trial study, volunteer college students were exposed to a viral challenge. The group who received amantadine (100 milligrams 18 hours before viral challenge) had less Asia influenza infections than the placebo group. in adults in 1976.\n\nDuring the 1980 influenza A epidemic, the first amantadine-resistance influenza viruses were reported. The frequency of amantadine resistance among influenza A (H3N2) viruses from 1991 and 1995 was as low as 0.8%. In 2004, the resistance frequency increased to 12.3%. A year later, resistance increase significantly to 96%, 72%, and 14.5% in China, South Korea, and the United States, respectively. By 2006, 90.6% of H3N2 strains and 15.6% of H1N1 were amantadine resistant. A majority of the amantadine-resistant H3N2 isolates (98.2%) was found to contain an S31N mutation in the M2 transmembrane domain that confers resistance to amantadine. Currently, adamantane resistance is high among circulating influenza A viruses. Thus, they are no longer recommended for treatment of influenza A.\n\n===Parkinson's disease===\nAn incidental finding in 1969 prompted investigations about amantadine's effectiveness for treating symptoms of Parkinson's disease. Additional studies followed patients for greater lengths of time and in different combinations of neurological drugs. It was found to be a safe drug that could be used over long periods of time with few side effects as monotherapy or in combination with L-dopa or anticholinergic drugs.","wiki_society_and_culture":"==Society and culture==\n===Names===\nBrand names of amantadine include Gocovri, Symadine, and Symmetrel.\n\n===Recreational use===\nRecreational use of amantadine at supratherapeutic doses has been reported. Recreational use of the related drug memantine has similarly been reported. In Western countries and according to international livestock regulations, amantadine is approved only for use in humans. Chickens in China have received an estimated 2.6 billion doses of amantadine.\n\nIn September 2015, the U.S. FDA announced the recall of Dingo Chip Twists \"Chicken in the Middle\" dog treats because the product has the potential to be contaminated with amantadine."},"commercial":{"launchDate":"1968","_launchSource":"DrugCentral (FDA 1968-02-14, ENDO PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/144","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMANTADINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMANTADINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Amantadine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:39:58.337078","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:18:05.955675+00:00","fieldsConflicting":4,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"amiodarone","drugSlug":"amiodarone","fdaApproval":"1985-12-24","patentExpiry":"Mar 13, 2029","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amitriptyline","drugSlug":"amitriptyline","fdaApproval":"1961-04-07","genericCount":33,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"astemizole","drugSlug":"astemizole","fdaApproval":"1988-12-31","relationship":"same-target"},{"drugName":"azaperone","drugSlug":"azaperone","fdaApproval":"","relationship":"same-target"},{"drugName":"benzatropine","drugSlug":"benzatropine","fdaApproval":"1954-03-05","relationship":"same-target"},{"drugName":"buspirone","drugSlug":"buspirone","fdaApproval":"1986-09-29","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"butenafine","drugSlug":"butenafine","fdaApproval":"1996-10-18","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"caramiphen","drugSlug":"caramiphen","fdaApproval":"","relationship":"same-target"},{"drugName":"cefapirin","drugSlug":"cefapirin","fdaApproval":"1974-03-12","relationship":"same-target"},{"drugName":"chloroquine","drugSlug":"chloroquine","fdaApproval":"1949-10-31","patentStatus":"Unknown","relationship":"same-target"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"amantadine","indications":{"approved":[{"name":"Arteriosclerotic Parkinsonism","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Extrapyramidal disease","source":"DrugCentral","snomedId":76349003,"regulator":"FDA"},{"name":"Influenza A Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Influenza due to Influenza A virus","source":"DrugCentral","snomedId":442438000,"regulator":"FDA"},{"name":"Parkinson's disease","source":"DrugCentral","snomedId":49049000,"regulator":"FDA","usPrevalence":1000000,"globalPrevalence":8500000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Parkinsonism","source":"DrugCentral","snomedId":32798002,"regulator":"FDA"},{"name":"Postencephalitic parkinsonism","source":"DrugCentral","snomedId":19972008,"regulator":"FDA"}],"offLabel":[{"name":"Arousal post traumatic brain injury","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":7,"evidenceLevel":"emerging"},{"name":"Cognitive Impairment following Traumatic Brain Injury","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":6,"evidenceLevel":"emerging"},{"name":"Cognitive impairment following traumatic brain injury","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":6,"evidenceLevel":"emerging"},{"name":"Fatigue due to Multiple Sclerosis","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Jakob-Creutzfeldt disease","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":16,"evidenceLevel":"moderate"}],"pipeline":[]},"currentOwner":"Endo Pharms","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"amiodarone","brandName":"amiodarone","genericName":"amiodarone","approvalYear":"1985","relationship":"same-target"},{"drugId":"amitriptyline","brandName":"amitriptyline","genericName":"amitriptyline","approvalYear":"1961","relationship":"same-target"},{"drugId":"astemizole","brandName":"astemizole","genericName":"astemizole","approvalYear":"1988","relationship":"same-target"},{"drugId":"azaperone","brandName":"azaperone","genericName":"azaperone","approvalYear":"","relationship":"same-target"},{"drugId":"benzatropine","brandName":"benzatropine","genericName":"benzatropine","approvalYear":"1954","relationship":"same-target"},{"drugId":"buspirone","brandName":"buspirone","genericName":"buspirone","approvalYear":"1986","relationship":"same-target"},{"drugId":"butenafine","brandName":"butenafine","genericName":"butenafine","approvalYear":"1996","relationship":"same-target"},{"drugId":"caramiphen","brandName":"caramiphen","genericName":"caramiphen","approvalYear":"","relationship":"same-target"},{"drugId":"cefapirin","brandName":"cefapirin","genericName":"cefapirin","approvalYear":"1974","relationship":"same-target"},{"drugId":"chloroquine","brandName":"chloroquine","genericName":"chloroquine","approvalYear":"1949","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT04367883","phase":"","title":"Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection","status":"RECRUITING","sponsor":"Consorci Sanitari de Terrassa","startDate":"2020-03-01","conditions":["COVID19","Influenza Vaccination","ACE Inhibitors","ARB","Antihistamine Allergy","Amantadine"],"enrollment":3000,"completionDate":"2028-02-24"},{"nctId":"NCT05504057","phase":"","title":"Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection","status":"RECRUITING","sponsor":"Consorci Sanitari de Terrassa","startDate":"2020-03-01","conditions":["COVID-19"],"enrollment":140660,"completionDate":"2028-02-24"},{"nctId":"NCT07470606","phase":"PHASE2","title":"Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain","status":"NOT_YET_RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2026-03","conditions":["Brain Tumor"],"enrollment":108,"completionDate":"2031-03"},{"nctId":"NCT07151378","phase":"PHASE3","title":"Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease","status":"RECRUITING","sponsor":"University Hospital Tuebingen","startDate":"2025-10-27","conditions":["PARKINSON DISEASE (Disorder)"],"enrollment":150,"completionDate":"2030-09-22"},{"nctId":"NCT04302870","phase":"PHASE2,PHASE3","title":"Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial","status":"RECRUITING","sponsor":"University of Edinburgh","startDate":"2020-02-27","conditions":["Motor Neuron Disease, Amyotrophic Lateral Sclerosis"],"enrollment":1150,"completionDate":"2030-12"},{"nctId":"NCT04966546","phase":"EARLY_PHASE1","title":"Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD)","status":"WITHDRAWN","sponsor":"University of New Mexico","startDate":"2022-06-01","conditions":["Chronic Subdural Hematoma"],"enrollment":0,"completionDate":"2025-12-01"},{"nctId":"NCT03553875","phase":"PHASE3","title":"Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2018-11-13","conditions":["Autism","Autism Spectrum Disorder","Nonverbal Learning Disability"],"enrollment":25,"completionDate":"2025-11-25"},{"nctId":"NCT07421427","phase":"NA","title":"Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome","status":"RECRUITING","sponsor":"Cairo University","startDate":"2026-02-21","conditions":["Amantadine","Duloxetine","Pregabalin","Mastectomy","Pain Syndrome"],"enrollment":150,"completionDate":"2027-01-01"},{"nctId":"NCT07248228","phase":"PHASE2","title":"Memory Avoidance Whole Brain Radiotherapy vs Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)","status":"NOT_YET_RECRUITING","sponsor":"Case Comprehensive Cancer Center","startDate":"2026-03","conditions":["Brain Metastases"],"enrollment":90,"completionDate":"2028-11"},{"nctId":"NCT07417670","phase":"PHASE4","title":"Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease","status":"COMPLETED","sponsor":"Carnot Laboratories","startDate":"2024-10-04","conditions":["Alzheimer Disease"],"enrollment":105,"completionDate":"2025-08-18"},{"nctId":"NCT03527472","phase":"PHASE2","title":"Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2018-08-23","conditions":["Lupus Erythematosus, Systemic"],"enrollment":111,"completionDate":"2026-02-28"},{"nctId":"NCT04857983","phase":"PHASE2,PHASE3","title":"Memantine Augmentation of Targeted Cognitive Training in Schizophrenia","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2021-07-06","conditions":["Schizophrenia","Schizoaffective Disorder"],"enrollment":62,"completionDate":"2025-03-30"},{"nctId":"NCT06055244","phase":"PHASE2","title":"Amantadine Therapy for Cognitive Impairment in Long COVID","status":"COMPLETED","sponsor":"Ohio State University","startDate":"2023-12-07","conditions":["Long COVID","Post-COVID19 Condition","Post-Acute COVID19 Syndrome"],"enrollment":64,"completionDate":"2025-12-29"},{"nctId":"NCT07351773","phase":"NA","title":"Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease","status":"COMPLETED","sponsor":"Taizhou Second People's Hospital","startDate":"2025-01-26","conditions":["Alzheimer's Disease(AD)","Cognitive Dysfunction"],"enrollment":40,"completionDate":"2025-11-29"},{"nctId":"NCT05063851","phase":"PHASE2","title":"The Use of Memantine for Prevention of Alzheimer's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Virginia","startDate":"2021-10-11","conditions":["Alzheimer Disease"],"enrollment":32,"completionDate":"2026-12"},{"nctId":"NCT04804644","phase":"PHASE3","title":"Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability","status":"RECRUITING","sponsor":"NRG Oncology","startDate":"2021-06-10","conditions":["Metastatic Lung Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Brain","Recurrent Lung Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8"],"enrollment":200,"completionDate":"2030-07-01"},{"nctId":"NCT03550391","phase":"PHASE3","title":"Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","status":"RECRUITING","sponsor":"Canadian Cancer Trials Group","startDate":"2018-11-22","conditions":["Brain Metastases"],"enrollment":206,"completionDate":"2027-12-31"},{"nctId":"NCT03703856","phase":"PHASE4","title":"Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, San Diego","startDate":"2019-01-31","conditions":["Alzheimer Disease"],"enrollment":53,"completionDate":"2025-12-30"},{"nctId":"NCT06833203","phase":"NA","title":"Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome","status":"COMPLETED","sponsor":"Cairo University","startDate":"2023-12-01","conditions":["Amantadine","Pregabalin","Post-thoracotomy Pain Syndrome"],"enrollment":60,"completionDate":"2025-05-01"},{"nctId":"NCT05418049","phase":"PHASE2","title":"Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2022-09-08","conditions":["Fragile X Syndrome"],"enrollment":45,"completionDate":"2026-03-05"},{"nctId":"NCT04939597","phase":"PHASE3","title":"A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2022-05-10","conditions":["Central Nervous System Carcinoma"],"enrollment":192,"completionDate":"2027-09-30"},{"nctId":"NCT02144584","phase":"EARLY_PHASE1","title":"Memantine for Enhanced Stroke Recovery","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Utah","startDate":"2014-01","conditions":["Ischemic Stroke","Upper Extremity Weakness"],"enrollment":20,"completionDate":"2026-12"},{"nctId":"NCT07251023","phase":"PHASE3","title":"Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia","status":"RECRUITING","sponsor":"Bigespas LTD","startDate":"2025-11-20","conditions":["Alzheimer Type Dementia"],"enrollment":450,"completionDate":"2027-05"},{"nctId":"NCT05013892","phase":"PHASE2","title":"NTS-WBRT in Brain Metastases","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2022-02-08","conditions":["Brain Metastases"],"enrollment":41,"completionDate":"2027-12-31"},{"nctId":"NCT05796752","phase":"PHASE2,PHASE3","title":"Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Chicago","startDate":"2023-08-02","conditions":["Skin-Picking","Trichotillomania (Hair-Pulling Disorder)"],"enrollment":26,"completionDate":"2026-06"},{"nctId":"NCT06501638","phase":"PHASE2","title":"Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats","status":"COMPLETED","sponsor":"Shanghai East Hospital","startDate":"2024-08-29","conditions":["Atrial Premature Beats, Contractions, or Systoles"],"enrollment":256,"completionDate":"2025-05-16"},{"nctId":"NCT06052787","phase":"PHASE3","title":"Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2023-09-01","conditions":["Traumatic Brain Injury"],"enrollment":150,"completionDate":"2025-08-01"},{"nctId":"NCT07164794","phase":"PHASE2","title":"Memantine Hydrochloride in Prostate Cancer Patients","status":"NOT_YET_RECRUITING","sponsor":"Bin Xu","startDate":"2025-11","conditions":["Metastatic Castration-resistant Prostate Cancer (mCRPC)","Prostate Cancer","Neuroendocrine Prostate Cancer (NEPC)"],"enrollment":15,"completionDate":"2028-06"},{"nctId":"NCT00262470","phase":"PHASE1,PHASE2","title":"Treatment of Orthostatic Intolerance","status":"ACTIVE_NOT_RECRUITING","sponsor":"Satish R. Raj","startDate":"1997-04","conditions":["Tachycardia","Chronic Orthostatic Intolerance"],"enrollment":150,"completionDate":"2029-12"},{"nctId":"NCT06789757","phase":"PHASE2","title":"The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC)","status":"RECRUITING","sponsor":"Inova Health Care Services","startDate":"2025-02-25","conditions":["Hepatocellular Carcinoma"],"enrollment":19,"completionDate":"2028-01-27"},{"nctId":"NCT06007846","phase":"PHASE2,PHASE3","title":"A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer","status":"RECRUITING","sponsor":"Inova Health Care Services","startDate":"2023-07-31","conditions":["Hepatocellular Carcinoma","Cirrhosis"],"enrollment":12,"completionDate":"2026-08-31"},{"nctId":"NCT06041789","phase":"PHASE2","title":"Effect of Acetylcholinesterase Inhibitors on Bone Metabolism","status":"RECRUITING","sponsor":"Duke University","startDate":"2025-02-03","conditions":["Osteoporosis"],"enrollment":45,"completionDate":"2026-11"},{"nctId":"NCT02466191","phase":"PHASE4","title":"Treatment of Pendular Nystagmus in OPT","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2015-06","conditions":["Pendular Nystagmus","Oculopalatal Tremor"],"enrollment":7,"completionDate":"2016-01"},{"nctId":"NCT01744444","phase":"PHASE2","title":"Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2012-11","conditions":["Pendular Nystagmus Patients With Multiple Sclerosis"],"enrollment":10,"completionDate":"2013-07"},{"nctId":"NCT06727773","phase":"PHASE2","title":"Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer","status":"RECRUITING","sponsor":"UNC Lineberger Comprehensive Cancer Center","startDate":"2025-05-07","conditions":["Breast Cancer","Locally Advanced Breast Cancer","Cognitive Impairment","Cognitive Decline","Cognitive Change","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III"],"enrollment":90,"completionDate":"2028-10-31"},{"nctId":"NCT06234462","phase":"PHASE2","title":"A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid","status":"WITHDRAWN","sponsor":"University of Texas Southwestern Medical Center","startDate":"2025-06","conditions":["Long COVID","Post-Acute COVID-19 Syndrome"],"enrollment":0,"completionDate":"2025-10-01"},{"nctId":"NCT07125222","phase":"PHASE2","title":"Use of Gocovri to Improve Disability Due to Radiation Encephalopathy","status":"NOT_YET_RECRUITING","sponsor":"Weill Medical College of Cornell University","startDate":"2025-09","conditions":["Radiation Encephalopathy"],"enrollment":24,"completionDate":"2028-08"},{"nctId":"NCT07113015","phase":"NA","title":"A Study Comparing Propranolol and Amantadine for Reducing Tremors in People With Parkinson's Disease","status":"COMPLETED","sponsor":"Multan Medical And Dental College","startDate":"2024-07-05","conditions":["Parkinson Disease (PD)","Tremor"],"enrollment":220,"completionDate":"2024-12-02"},{"nctId":"NCT00199719","phase":"PHASE2","title":"Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM","status":"COMPLETED","sponsor":"University Hospital, Limoges","startDate":"2003-06","conditions":["Chronic Hepatitis C"],"enrollment":30,"completionDate":"2006-09"},{"nctId":"NCT06253923","phase":"PHASE2","title":"Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).","status":"ACTIVE_NOT_RECRUITING","sponsor":"SHINKEI Therapeutics, Inc","startDate":"2024-06-01","conditions":["Traumatic Brain Injury"],"enrollment":45,"completionDate":"2025-08"},{"nctId":"NCT02994719","phase":"","title":"Gait Analysis in Neurological Disease","status":"RECRUITING","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2016-03-01","conditions":["Parkinson's Disease","Parkinsonian Disorders","Atypical Parkinson Disease","Progressive Supranuclear Palsy","Multiple System Atrophy","Corticobasal Degeneration","Gait, Frontal","Huntington Disease"],"enrollment":120,"completionDate":"2026-06-20"},{"nctId":"NCT04588246","phase":"PHASE3","title":"Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery","status":"TERMINATED","sponsor":"NRG Oncology","startDate":"2021-08-05","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Small Cell Carcinoma","Metastatic Malignant Breast Neoplasm","Metastatic Malignant Digestive System Neoplasm","Metastatic Malignant Neoplasm in the Brain","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Recurrent Brain Neoplasm","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8"],"enrollment":19,"completionDate":"2024-08-06"},{"nctId":"NCT04539951","phase":"PHASE2","title":"Pragmatic Trial of Obsessive-compulsive Disorder","status":"RECRUITING","sponsor":"Shanghai Mental Health Center","startDate":"2020-09-22","conditions":["Obsessive-Compulsive Disorder"],"enrollment":1600,"completionDate":"2028-12-31"},{"nctId":"NCT01430351","phase":"PHASE1","title":"Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2011-09-14","conditions":["Glioblastoma","Gliosarcoma","Supratentorial Glioblastoma"],"enrollment":144,"completionDate":"2025-02-02"},{"nctId":"NCT05045950","phase":"PHASE2","title":"Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique","status":"RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2021-11-17","conditions":["Brain Metastases"],"enrollment":53,"completionDate":"2029-05"},{"nctId":"NCT02360215","phase":"PHASE3","title":"Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases","status":"COMPLETED","sponsor":"NRG Oncology","startDate":"2015-07","conditions":["Cognitive Impairment","Metastatic Malignant Neoplasm in the Brain","Solid Neoplasm"],"enrollment":518,"completionDate":"2019-08-26"},{"nctId":"NCT06275035","phase":"PHASE3","title":"Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI","status":"RECRUITING","sponsor":"Tata Memorial Centre","startDate":"2024-02-22","conditions":["Neurocognitive Dysfunction"],"enrollment":101,"completionDate":"2031-01"},{"nctId":"NCT06914310","phase":"PHASE2,PHASE3","title":"Memantine as an Additive Therapy in Patients With Traumatic Brain Injury","status":"NOT_YET_RECRUITING","sponsor":"Mansoura University","startDate":"2025-03-25","conditions":["Mild Traumatic Brain Injury","Moderate Traumatic Brain Injury (TBI)"],"enrollment":80,"completionDate":"2025-11-30"},{"nctId":"NCT05140148","phase":"PHASE2","title":"Promoting Recovery After STroke With Amantadine","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2022-02-01","conditions":["Stroke, Ischemic","Stroke Hemorrhagic"],"enrollment":60,"completionDate":"2026-06-30"},{"nctId":"NCT06817200","phase":"PHASE2","title":"The Effect of Amantadine as add-on Therapy for Motor Fluctuations in Advanced Parkinson's Disease: a Randomized Double-blinded Placebo-controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Toulouse","startDate":"2025-05-01","conditions":["Parkinson Disease (PD)"],"enrollment":132,"completionDate":"2027-08-31"},{"nctId":"NCT04117178","phase":"PHASE4","title":"Monitoring Anti-Dementia Drugs by Serum Levels","status":"COMPLETED","sponsor":"Zealand University Hospital","startDate":"2020-02-04","conditions":["Dementia","Dementia With Lewy Bodies","Dementia in Parkinsons Disease","Dementia Alzheimers","Alzheimer Disease"],"enrollment":132,"completionDate":"2023-02-16"},{"nctId":"NCT04789915","phase":"PHASE1","title":"Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis","status":"RECRUITING","sponsor":"Bjorn H. Ebdrup","startDate":"2021-05-26","conditions":["Psychosis","Negative Symptoms With Primary Psychotic Disorder"],"enrollment":46,"completionDate":"2026-12-31"},{"nctId":"NCT04217694","phase":"EARLY_PHASE1","title":"Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2020-02-17","conditions":["Malignant Central Nervous System Neoplasm","Primary Central Nervous System Neoplasm"],"enrollment":18,"completionDate":"2024-08-12"},{"nctId":"NCT06679387","phase":"PHASE2","title":"\"The Effect of Memantine on the Prevention and Amelioration of Paclitaxel-induced Toxicity in Breast Cancer Patients\"","status":"RECRUITING","sponsor":"Ain Shams University","startDate":"2024-10-30","conditions":["Breast Cancer Early Stage Breast Cancer (Stage 1-3)"],"enrollment":80,"completionDate":"2025-10"},{"nctId":"NCT04387773","phase":"PHASE4","title":"Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2020-11-05","conditions":["Parkinson Disease"],"enrollment":8,"completionDate":"2022-09-30"},{"nctId":"NCT06594172","phase":"PHASE2","title":"Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy","status":"NOT_YET_RECRUITING","sponsor":"Affiliated Cancer Hospital & Institute of Guangzhou Medical University","startDate":"2024-09-10","conditions":["Radiation Disease","Cognitive Impairment","Drug Effect"],"enrollment":67,"completionDate":"2027-06-30"},{"nctId":"NCT04792645","phase":"PHASE2","title":"Memantine in Body Focused Repetitive Behaviors","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2021-06-15","conditions":["Trichotillomania (Hair-Pulling Disorder)","Dermatillomania"],"enrollment":100,"completionDate":"2022-07-08"},{"nctId":"NCT06337994","phase":"PHASE3","title":"Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury","status":"COMPLETED","sponsor":"Assiut University","startDate":"2024-01-01","conditions":["Treatment of Cognitive Deficits After Traumatic Brain Injury"],"enrollment":60,"completionDate":"2024-08-01"},{"nctId":"NCT01333865","phase":"PHASE4","title":"A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2010-01","conditions":["Autism Spectrum Disorders"],"enrollment":25,"completionDate":"2014-07"},{"nctId":"NCT01972074","phase":"PHASE3","title":"Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2015-02-17","conditions":["Autism Spectrum Disorder"],"enrollment":84,"completionDate":"2018-05-07"},{"nctId":"NCT06443827","phase":"PHASE2","title":"Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness","status":"ACTIVE_NOT_RECRUITING","sponsor":"Azienda Sanitaria dell'Alto Adige","startDate":"2018-09-15","conditions":["Amantadine","Consciousness Disorders","Electroencephalography"],"enrollment":18,"completionDate":"2024-09-30"},{"nctId":"NCT03430817","phase":"PHASE4","title":"Citicholine-Amantadine Trial in Traumatic Brain Injury","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2017-12-07","conditions":["Intensive Care Unit"],"enrollment":45,"completionDate":"2024-04-20"},{"nctId":"NCT05664464","phase":"PHASE1,PHASE2","title":"Glutamate Inhibitors in Glioblastoma","status":"RECRUITING","sponsor":"University of Zurich","startDate":"2023-01-01","conditions":["Glioblastoma"],"enrollment":120,"completionDate":"2026-12"},{"nctId":"NCT04698525","phase":"PHASE3","title":"Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.","status":"COMPLETED","sponsor":"Universidad Autonoma de San Luis Potosí","startDate":"2019-02-15","conditions":["Migraine Headache"],"enrollment":33,"completionDate":"2020-01-15"},{"nctId":"NCT04834427","phase":"PHASE4","title":"Safety and Efficacy Evaluation of S (+) - Ketamine in Children","status":"ENROLLING_BY_INVITATION","sponsor":"Chinese PLA General Hospital","startDate":"2022-04-20","conditions":["S-ketamine","Esketamine","Acute Pain","Postoperative Pain","Analgesia","Hyperalgesia","Delirium","Depression, Anxiety","Children"],"enrollment":3000,"completionDate":"2024-12-04"},{"nctId":"NCT03670095","phase":"PHASE1","title":"Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions","status":"COMPLETED","sponsor":"H. Lundbeck A/S","startDate":"2018-08-28","conditions":["Healthy"],"enrollment":64,"completionDate":"2018-12-24"},{"nctId":"NCT04530006","phase":"NA","title":"Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma","status":"UNKNOWN","sponsor":"CancerCare Manitoba","startDate":"2020-12-02","conditions":["Glioblastoma Multiforme"],"enrollment":20,"completionDate":"2025-08"},{"nctId":"NCT05479032","phase":"PHASE2","title":"Amantadine for Neuroenhancement in Acute Patients Study","status":"UNKNOWN","sponsor":"University Hospital Tuebingen","startDate":"2023-03-01","conditions":["Disorder of Consciousness"],"enrollment":50,"completionDate":"2024-12-31"},{"nctId":"NCT00401167","phase":"PHASE4","title":"Memantine for Agitation and Aggression in Severe Alzheimer's Disease","status":"COMPLETED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2006-11","conditions":["Alzheimer's Disease"],"enrollment":31,"completionDate":"2010-01"},{"nctId":"NCT05809414","phase":"PHASE3","title":"Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis","status":"UNKNOWN","sponsor":"Hospital San Carlos, Madrid","startDate":"2022-11-28","conditions":["Multiple Sclerosis","Fatigue"],"enrollment":144,"completionDate":"2025-02-28"},{"nctId":"NCT00755898","phase":"PHASE2","title":"Urinary Excretion of Acetylamantadine by Cancer Patients","status":"COMPLETED","sponsor":"University of Manitoba","startDate":"2003-12","conditions":["Cancer"],"enrollment":150,"completionDate":"2008-07"},{"nctId":"NCT00693121","phase":"PHASE4","title":"Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State","status":"COMPLETED","sponsor":"Methodist Rehabilitation Center","startDate":"2003-04","conditions":["Traumatic Brain Injury","Posttraumatic Confusional State","Delirium"],"enrollment":79,"completionDate":"2019-03"},{"nctId":"NCT04936126","phase":"PHASE4","title":"Comparison of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment Resistant Depression","status":"UNKNOWN","sponsor":"All India Institute of Medical Sciences, Bhubaneswar","startDate":"2021-08-07","conditions":["Treatment Resistant Depression"],"enrollment":150,"completionDate":"2024-09-07"},{"nctId":"NCT03194906","phase":"PHASE2","title":"Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors","status":"COMPLETED","sponsor":"St. Jude Children's Research Hospital","startDate":"2017-11-07","conditions":["Glioma of Brain","Craniopharyngioma","Ependymoma","Germ Cell Tumor"],"enrollment":34,"completionDate":"2023-06-28"},{"nctId":"NCT02304302","phase":"PHASE2","title":"Down Syndrome Memantine Follow-up Study","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2014-10","conditions":["Down Syndrome","Intellectual Disability"],"enrollment":160,"completionDate":"2020-07-22"},{"nctId":"NCT02580305","phase":"PHASE2","title":"SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study","status":"COMPLETED","sponsor":"Suven Life Sciences Limited","startDate":"2015-09","conditions":["Alzheimer's Disease"],"enrollment":564,"completionDate":"2019-11-07"},{"nctId":"NCT05834231","phase":"PHASE1,PHASE2","title":"Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2023-08","conditions":["Cancer"],"enrollment":60,"completionDate":"2024-10"},{"nctId":"NCT04033419","phase":"PHASE2","title":"Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer","status":"COMPLETED","sponsor":"UNC Lineberger Comprehensive Cancer Center","startDate":"2019-09-25","conditions":["Cognitive Decline","Chemo-brain"],"enrollment":55,"completionDate":"2022-04-04"},{"nctId":"NCT04527289","phase":"PHASE4","title":"Impact of Amantadine on Traumatic Brain Injury","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2020-09-30","conditions":["Trauma, Brain"],"enrollment":50,"completionDate":"2021-10-30"},{"nctId":"NCT03729258","phase":"PHASE3","title":"Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.","status":"UNKNOWN","sponsor":"Neutec Ar-Ge San ve Tic A.Ş","startDate":"2019-05-15","conditions":["Sinusitis","Sinusitis, Acute","Rhinosinusitis","Rhinosinusitis Acute","Sinus Infection"],"enrollment":100,"completionDate":"2023-12-01"},{"nctId":"NCT01071395","phase":"PHASE4","title":"Validation of Dyskinesia Rating Scales","status":"COMPLETED","sponsor":"Rush University Medical Center","startDate":"2010-01","conditions":["Parkinson's Disease"],"enrollment":68,"completionDate":"2013-06"},{"nctId":"NCT05667077","phase":"PHASE2","title":"The Effect of Amantadine on Post-COVD-19 Fatigue","status":"UNKNOWN","sponsor":"Shahid Beheshti University of Medical Sciences","startDate":"2022-12-26","conditions":["Post-COVID-19 Syndrome"],"enrollment":83,"completionDate":"2023-01-10"},{"nctId":"NCT03860597","phase":"PHASE4","title":"Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2018-04-01","conditions":["Schizophrenia","Schizo Affective Disorder","Schizoaffective Disorder","Healthy"],"enrollment":42,"completionDate":"2021-03-31"},{"nctId":"NCT00646204","phase":"PHASE4","title":"Namenda (Memantine) for Non-motor Symptoms in Parkinson's Disease","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2006-04","conditions":["Parkinson's Disease"],"enrollment":40,"completionDate":"2009-03"},{"nctId":"NCT02118727","phase":"PHASE2","title":"Therapy in Amyotrophic Lateral Sclerosis (TAME)","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2018-11-07","conditions":["Amyotrophic Lateral Sclerosis","Frontal Temporal Dementia"],"enrollment":89,"completionDate":"2021-07-22"},{"nctId":"NCT01555697","phase":"PHASE1,PHASE2","title":"Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2014-07","conditions":["Schizophrenia"],"enrollment":80,"completionDate":"2019-06-01"},{"nctId":"NCT04244058","phase":"EARLY_PHASE1","title":"Changes in Glutamatergic Neurotransmission of Severe TBI Patients","status":"SUSPENDED","sponsor":"Weill Medical College of Cornell University","startDate":"2020-09-23","conditions":["Disorder of Consciousness","Traumatic Brain Injury"],"enrollment":30,"completionDate":"2023-06-30"},{"nctId":"NCT04952519","phase":"PHASE3","title":"Efficacy of Amantadine Treatment in COVID-19 Patients","status":"TERMINATED","sponsor":"Noblewell","startDate":"2021-03-30","conditions":["Patients With Moderate or Severe COVID-19"],"enrollment":193,"completionDate":"2022-03-10"},{"nctId":"NCT05538507","phase":"PHASE2","title":"Efficacy of Chinese Traditional Medicine \"Smart Soup\" in Cognition and Behavior Regulation in Alzheimer's Disease","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2022-06-01","conditions":["Alzheimer Disease","Mild Cognitive Impairment"],"enrollment":180,"completionDate":"2024-06"},{"nctId":"NCT05531383","phase":"NA","title":"Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury","status":"UNKNOWN","sponsor":"Minia University","startDate":"2021-11-26","conditions":["Traumatic Brain Injury"],"enrollment":70,"completionDate":"2024-07-09"},{"nctId":"NCT00779324","phase":"NA","title":"Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2009-08","conditions":["Brain Injury","Aggression"],"enrollment":168,"completionDate":"2013-05"},{"nctId":"NCT05430867","phase":"PHASE4","title":"Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2022-07-01","conditions":["Treatment","Efficacy","Safety","Alzheimer Disease"],"enrollment":150,"completionDate":"2024-12-31"},{"nctId":"NCT04273737","phase":"PHASE4","title":"Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy","status":"TERMINATED","sponsor":"Columbia University","startDate":"2020-02-28","conditions":["Cerebral Palsy"],"enrollment":11,"completionDate":"2022-02-22"},{"nctId":"NCT00800514","phase":"NA","title":"Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)","status":"WITHDRAWN","sponsor":"Wake Forest University Health Sciences","startDate":"2009-01","conditions":["Traumatic Brain Injury"],"enrollment":0,"completionDate":"2010-11"},{"nctId":"NCT00627250","phase":"NA","title":"Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2003-03","conditions":["Irritable Mood","Aggression","Traumatic Brain Injury"],"enrollment":76,"completionDate":"2007-11"},{"nctId":"NCT00371059","phase":"PHASE4","title":"Memantine for Agitation in Dementia","status":"COMPLETED","sponsor":"East Kent Hospitals University NHS Foundation Trust","startDate":"2007-09","conditions":["DEMENTIA"],"enrollment":153,"completionDate":"2009-09"},{"nctId":"NCT03779672","phase":"PHASE4","title":"Memantine for Epileptic Encephalopathy","status":"COMPLETED","sponsor":"Kenneth Myers, MD","startDate":"2019-02-07","conditions":["Epileptic Encephalopathy, Childhood-Onset"],"enrollment":30,"completionDate":"2022-02-08"},{"nctId":"NCT02153632","phase":"PHASE3","title":"Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID","status":"TERMINATED","sponsor":"Adamas Pharmaceuticals, Inc.","startDate":"2014-07-30","conditions":["Parkinson's Disease","Levodopa Induced Dyskinesia (LID)"],"enrollment":135,"completionDate":"2016-05-20"},{"nctId":"NCT02153645","phase":"PHASE3","title":"Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.","status":"TERMINATED","sponsor":"Adamas Pharmaceuticals, Inc.","startDate":"2014-08-18","conditions":["Parkinson's Disease","Levodopa Induced Dyskinesias (LID)"],"enrollment":87,"completionDate":"2016-05-20"},{"nctId":"NCT03567057","phase":"PHASE3","title":"A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment","status":"COMPLETED","sponsor":"Adamas Pharmaceuticals, Inc.","startDate":"2018-07-18","conditions":["Multiple Sclerosis","Walking Impairment"],"enrollment":424,"completionDate":"2021-04-18"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule, Solution, Tablet","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"AMANTADINE HYDROCHLORIDE"},{"form":"CAPSULE","route":"ORAL","productName":"Amantadine"},{"form":"CAPSULE","route":"ORAL","productName":"Amantadine HCL"},{"form":"CAPSULE","route":"ORAL","productName":"Amantadine HCl"},{"form":"CAPSULE","route":"ORAL","productName":"Amantadine Hydrochloride"},{"form":"CAPSULE","route":"ORAL","productName":"Amantadine hydrochloride"},{"form":"CAPSULE","route":"ORAL","productName":"amantadine"},{"form":"CAPSULE","route":"ORAL","productName":"amantadine hydrochloride"},{"form":"CAPSULE, COATED PELLETS","route":"ORAL","productName":"GOCOVRI"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Amantadine Hydrochloride"},{"form":"CAPSULE, LIQUID FILLED","route":"ORAL","productName":"Amantadine HCl"},{"form":"CAPSULE, LIQUID FILLED","route":"ORAL","productName":"Amantadine Hydrochloride"},{"form":"SOLUTION","route":"ORAL","productName":"AMANTADINE HYDROCHLORIDE"},{"form":"SOLUTION","route":"ORAL","productName":"Amantadine Hydrochloride"},{"form":"TABLET","route":"ORAL","productName":"AMANTADINE HYDROCHLORIDE"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147697","MMSL":"2543","NDDF":"001640","UNII":"BF4C9Z1J53","VUID":"4019601","CHEBI":"CHEBI:2618","VANDF":"4018546","INN_ID":"1816","RXNORM":"282415","UMLSCUI":"C0002403","chemblId":"CHEMBL660","ChEMBL_ID":"CHEMBL660","KEGG_DRUG":"D00777","DRUGBANK_ID":"DB00915","PDB_CHEM_ID":" 308","PUBCHEM_CID":"2130","SNOMEDCT_US":"372763006","IUPHAR_LIGAND_ID":"4128","SECONDARY_CAS_RN":"665-66-7","MESH_DESCRIPTOR_UI":"D000547"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1968-","companyName":"Endo Pharms","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"16.0 hours","clearance":"4.8 mL/min/kg","bioavailability":"90%","fractionUnbound":"0.33%","volumeOfDistribution":"6.6 L/kg"},"publicationCount":4559,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"N04BB01","allCodes":["N04BB01"]},"biosimilarFilings":[],"originalDeveloper":"Endo Pharms","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":30,"_genericFilersChecked":true,"genericManufacturerList":["Actavis Elizabeth","Adaptis","Alembic","Athem","Aurobindo Pharma Usa","Bionpharma","Chartwell Molecular","Chartwell Rx","G And W Labs Inc","Heritage Pharma","Humanwell Puracap","Invagen Pharms","Jubilant Generics","Onesource Specialty","Ph Health","Pharm Assoc","Pharmobedient","Rising","Rubicon Research","Sandoz","Shree Hari Intl","Solvay","Strides Pharma","Teva Pharms","Upsher Smith Labs","Watson Labs","Watson Labs Inc","Zhejiang Jutai Pharm","Zydus","Zydus Pharms"],"status":"approved","companyName":"Endo Pharms","companyId":"endo","modality":"Small molecule","firstApprovalDate":"1968","enrichmentLevel":4,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":6,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:18:05.955675+00:00","fieldsConflicting":4,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}