{"id":"lacosamide-oral","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":["7 DRUG INTERACTIONS 7.1 Strong CYP3A4 or CYP2C9 Inhibitors Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in these patients. 7.2 Concomitant Medications that Affect Cardiac Conduction Lacosamide should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia. In such patients, obtaining an ECG before beginning lacosamide, and after lacosamide is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered lacosamide through the intravenous route [see Warnings and Precautions ( 5.3 )] ."],"commonSideEffects":["6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] Dizziness and Ataxia [see Warnings and Precautions ( 5.2 )] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions ( 5.3 )] Syncope [see Warnings and Precautions ( 5.4 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence ( 6.1 ) Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies ( 6.1 ) Pediatric patients: Adverse reactions are similar to those seen in adult patients ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact at +1-833-856-0880 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Lacosamide Oral Solution in Adults In the premarketing development of adjunctive therapy for partial-onset seizures, 1327 adult patients received lacosamide tablets in controlled and uncontrolled trials, of whom 1000 were treated for longer than 6 months, and 852 for longer than 12 months. The monotherapy development program for partial-onset seizures included 425 adult patients, 310 of whom were treated for longer than 6 months, and 254 for longer than 12 months. Partial-Onset Seizures Monotherapy Historical-Control Trial (Study 1) In the monotherapy trial for partial-onset seizures, 16% of patients randomized to receive lacosamide at the recommended doses of 300 and 400 mg/day discontinued from the trial as a result of an adverse reaction. The adverse reaction most commonly (≥1% on lacosamide) leading to discontinuation was dizziness. Adverse reactions that occurred in this study were generally similar to those that occurred in adjunctive placebo-controlled studies. One adverse reaction, insomnia, occurred at a rate of ≥2% and was not reported at a similar rate in previous studies. This adverse reaction has also been observed in postmarketing experience [see Adverse Reactions ( 6.2 )] . Because this study did not include a placebo control group, causality could not be established. Dizziness, headache, nausea, somnolence, and fatigue all occurred at lower incidences during the AED Withdrawal Phase and Monotherapy Phase, compared with the Titration Phase [see Clinical Studies ( 14.1 )] . Adjunctive Therapy Controlled Trials (Studies 2, 3, and 4) In adjunctive therapy controlled clinical trials for partial-onset seizures, the rate of discontinuation as a result of an adverse reaction was 8% and 17% in patients randomized to receive lacosamide at the recommended doses of 200 and 400 mg/day, respectively, 29% at 600 mg/day (1.5 times greater than the maximum recommended dose), and 5% in patients randomized to receive placebo. The adverse reactions most commonly (>1% on lacosamide and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and blurred vision. Table 4 gives the incidence of adverse reactions that occurred in ≥2% of adult patients with partial-onset seizures in the lacosamide total group and for which the incidence was greater than placebo. Table 4: Adverse Reactions Incidence in Adjunctive Therapy Pooled, Placebo-Controlled Trials in Adult Patients with Partial-Onset Seizures (Studies 2, 3, and 4) Adverse Reaction Placebo N=364 % Lacosamide 200 mg/day N=270 % Lacosamide 400 mg/day N=471 % Lacosamide 600 mg/day* N=203 % Lacosamide Total N=944 % Ear and labyrinth disorder Vertigo 1 5 3 4 4 Eye disorders Diplopia 2"],"contraindications":["4 CONTRAINDICATIONS None. None ( 4 )"]},"status":"discontinued","trials":["NCT00800215","NCT01530386","NCT00938912","NCT06866691","NCT01710657","NCT00861042","NCT03559673","NCT06969417","NCT03897348","NCT00522275","NCT01118962","NCT02408523","NCT00955357","NCT01620840","NCT01450111","NCT01964560","NCT04627285","NCT01921205","NCT05756621","NCT05632133","NCT03777956","NCT02477839","NCT02408549","NCT02582866","NCT01375387","NCT01530022","NCT05278221","NCT03271528","NCT00552305","NCT02192814","NCT00440518","NCT04519645","NCT00938431","NCT04144218","NCT01118949","NCT02124564","NCT01587339","NCT00515619","NCT05626140","NCT00350103","NCT01673282","NCT03204474","NCT00655486","NCT02972125","NCT01986608","NCT00655551","NCT01969851"],"aliases":["LCM","Vimpat"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Lacosamide oral","companyId":"ucb-biopharma-srl","ecosystem":[],"mechanism":{"drugClass":"","explanation":"1 INDICATIONS & USAGE Lacosamide oral solution is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.","oneSentence":"12.1 Mechanism of Action The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing."},"commercial":null,"references":[],"biosimilars":[],"companyName":"UCB Biopharma SRL","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"Lacosamide oral","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00800215","phase":"Phase 2","title":"A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":60,"indication":"Epilepsy","completionDate":"2004-11-30"},{"nctId":"NCT01530386","phase":"Phase 1","title":"A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":25,"indication":"Healthy Subjects","completionDate":"2012-07"},{"nctId":"NCT00938912","phase":"Phase 2","title":"An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy","status":"COMPLETED","sponsor":"UCB BIOSCIENCES, Inc.","isPivotal":false,"enrollment":366,"indication":"Epilepsy","completionDate":"2021-05-18"},{"nctId":"NCT06866691","phase":"Phase 4","title":"Comparison of Levetiracetam Versus Lacosamide for Seizure Prevention in Moderate to Severe Traumatic Brain Injured Patients","status":"RECRUITING","sponsor":"Wake Forest University Health 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Seizures ≥16 Years of Age Coming From the SP0994 Study","status":"NO_LONGER_AVAILABLE","sponsor":"UCB Biopharma S.P.R.L.","isPivotal":false,"enrollment":0,"indication":"Epilepsies, Partial","completionDate":""},{"nctId":"NCT06969417","phase":"NA","title":"Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia","status":"RECRUITING","sponsor":"CMH Kharian Medical College","isPivotal":false,"enrollment":50,"indication":"Herpes Zoster (HZ), Post Herpetic Neuralgia (PHN)","completionDate":"2025-09-30"},{"nctId":"NCT03897348","phase":"Phase 2","title":"A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder","status":"COMPLETED","sponsor":"University of California, San Francisco","isPivotal":false,"enrollment":4,"indication":"Alcohol Use Disorder","completionDate":"2019-06-12"},{"nctId":"NCT00522275","phase":"Phase 3","title":"An Open-label Extension Trial to Determine Safety and 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Mal","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":51,"indication":"Epilepsy","completionDate":"2009-02"},{"nctId":"NCT01964560","phase":"Phase 3","title":"A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures","status":"COMPLETED","sponsor":"UCB BIOSCIENCES, Inc.","isPivotal":true,"enrollment":540,"indication":"Epilepsy","completionDate":"2022-04-13"},{"nctId":"NCT04627285","phase":"Phase 3","title":"A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment","status":"COMPLETED","sponsor":"UCB Biopharma SRL","isPivotal":true,"enrollment":48,"indication":"Epilepsy","completionDate":"2025-02-12"},{"nctId":"NCT01921205","phase":"Phase 3","title":"A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Y","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":true,"enrollment":404,"indication":"Epilepsy","completionDate":"2017-01-24"},{"nctId":"NCT05756621","phase":"N/A","title":"SUPER-refractory Status Epilepticus After Cardiac Arrest: a Multicenter, Retrospective, Cohort Study of Dual Anti-glutamate Therapy With Ketamine and Perampanel","status":"RECRUITING","sponsor":"University of Milano Bicocca","isPivotal":false,"enrollment":80,"indication":"Status Epilepticus, Cardiac Arrest","completionDate":"2025-09-30"},{"nctId":"NCT05632133","phase":"Phase 3","title":"a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients","status":"COMPLETED","sponsor":"Kafrelsheikh University","isPivotal":true,"enrollment":200,"indication":"Effect of Drug, Migraine Disorders","completionDate":"2023-08-10"},{"nctId":"NCT03777956","phase":"Phase 2","title":"The Effect of Lacosamide in Peripheral Neuropathic Pain: a Randomized, Double-blind, Placebo Controlled, Phenotype-stratified Study","status":"TERMINATED","sponsor":"Danish Pain Research Center","isPivotal":false,"enrollment":63,"indication":"Neuropathic Pain, Neuropathy;Peripheral","completionDate":"2022-06-03"},{"nctId":"NCT02477839","phase":"Phase 3","title":"A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Y","status":"COMPLETED","sponsor":"UCB BIOSCIENCES, Inc.","isPivotal":true,"enrollment":255,"indication":"Epilepsy With Partial-onset Seizures","completionDate":"2020-05-28"},{"nctId":"NCT02408549","phase":"Phase 3","title":"An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive 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Center","isPivotal":false,"enrollment":66,"indication":"Alcohol Use Disorder","completionDate":"2020-08-31"},{"nctId":"NCT00552305","phase":"Phase 2","title":"An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":370,"indication":"Partial Epilepsies","completionDate":"2010-02"},{"nctId":"NCT02192814","phase":"Phase 3","title":"A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Seco","status":"COMPLETED","sponsor":"UCB Japan Co. Ltd.","isPivotal":true,"enrollment":9,"indication":"Epilepsy, Partial-onset Seizures","completionDate":"2014-12"},{"nctId":"NCT00440518","phase":"Phase 2","title":"A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day Lacosamide for Migraine Prophylaxis.","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":218,"indication":"Migraine","completionDate":"2008-07"},{"nctId":"NCT04519645","phase":"Phase 2","title":"A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures","status":"TERMINATED","sponsor":"UCB Biopharma SRL","isPivotal":false,"enrollment":29,"indication":"Electroencephalographic Neonatal Seizures, Epilepsy","completionDate":"2024-10-31"},{"nctId":"NCT00938431","phase":"Phase 2","title":"A Multicenter, Open-Label Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":47,"indication":"Epilepsy","completionDate":"2014-08"},{"nctId":"NCT04144218","phase":"Phase 4","title":"International Multicenter, Double-blind, Randomized, Placebo-controlled Evaluation of the Efficacy and Safety of Lacosamide in the Treatment of Pediatric Patients With Focal Refractory Epilepsy.","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","isPivotal":false,"enrollment":300,"indication":"Epilepsy","completionDate":"2021-12"},{"nctId":"NCT01118949","phase":"Phase 2","title":"An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy","status":"COMPLETED","sponsor":"UCB BIOSCIENCES, Inc.","isPivotal":false,"enrollment":49,"indication":"Epilepsy","completionDate":"2011-08"},{"nctId":"NCT02124564","phase":"Phase 3","title":"Multicenter, Open-Label, Long-Term Study to Investigate the Safety of Conversion to Lacosamide at Doses up to 600 mg/Day as Monotherapy in Japanese Adults With Partial-Onset Seizures With or Without S","status":"COMPLETED","sponsor":"UCB Japan Co. Ltd.","isPivotal":true,"enrollment":19,"indication":"Epilepsy, Partial-onset Seizures","completionDate":"2017-11-21"},{"nctId":"NCT01587339","phase":"N/A","title":"Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":6498,"indication":"Epilepsy","completionDate":"2011-07"},{"nctId":"NCT00515619","phase":"Phase 3","title":"An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":true,"enrollment":376,"indication":"Epilepsy","completionDate":"2010-08"},{"nctId":"NCT05626140","phase":"Phase 3","title":"COMPARISON OF EFFICACY OF DICLOFENAC VERSUS DICLOFENAC PLUS CODEINE AND DICLOFENAC PLUS LACOSAMIDE IN ACUTE SCIATICA","status":"COMPLETED","sponsor":"Pakistan Institute of Medical Sciences","isPivotal":true,"enrollment":120,"indication":"Sciatica Acute, Sciatica","completionDate":"2022-07-31"},{"nctId":"NCT00350103","phase":"Phase 3","title":"A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Using Two Different Tit","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":true,"enrollment":551,"indication":"Painful Diabetic Neuropathy","completionDate":"2007-06-29"},{"nctId":"NCT01673282","phase":"N/A","title":"A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking","status":"COMPLETED","sponsor":"UCB Pharma GmbH","isPivotal":false,"enrollment":315,"indication":"Focal Epilepsy With and Without Secondary Generalization","completionDate":"2015-07"},{"nctId":"NCT03204474","phase":"Phase 1","title":"A Randomized, Open-Label, Single-Dose, 2-Way Crossover Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects","status":"COMPLETED","sponsor":"UCB Biopharma S.P.R.L.","isPivotal":false,"enrollment":30,"indication":"Healthy Male Chinese Volunteers","completionDate":"2017-07-28"},{"nctId":"NCT00655486","phase":"Phase 3","title":"A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures","status":"COMPLETED","sponsor":"UCB BIOSCIENCES, Inc.","isPivotal":true,"enrollment":97,"indication":"Partial Epilepsies, Partial Onset Seizures","completionDate":"2010-06"},{"nctId":"NCT02972125","phase":"Phase 1","title":"A Single-Center, Open-Label, Randomized, Single-Oral Dose, 2-Way Cross-Over Study to Investigate the Bioequivalence Between Lacosamide Tablet and Dry Syrup in Healthy Male Japanese Subjects","status":"COMPLETED","sponsor":"UCB Biopharma S.P.R.L.","isPivotal":false,"enrollment":24,"indication":"Healthy Volunteers","completionDate":"2017-03"},{"nctId":"NCT01986608","phase":"Phase 1","title":"A Single Center Open-label, Randomized, Single-dose, 3-way Crossover Study to Compare the Safety, Tolerability, and Pharmacokinetics of Lacosamide Administered as Oral Tablet or Intravenous Infusion i","status":"COMPLETED","sponsor":"UCB Pharma SA","isPivotal":false,"enrollment":26,"indication":"Healthy Volunteers","completionDate":"2013-12"},{"nctId":"NCT00655551","phase":"Phase 3","title":"A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With ","status":"COMPLETED","sponsor":"UCB BIOSCIENCES, Inc.","isPivotal":true,"enrollment":100,"indication":"Partial Epilepsies, Partial Onset Seizures","completionDate":"2009-09"},{"nctId":"NCT01969851","phase":"Phase 2","title":"A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENER","status":"COMPLETED","sponsor":"UCB Pharma","isPivotal":false,"enrollment":55,"indication":"Epilepsy","completionDate":"2018-04-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"ORAL","dosage_text":"2 DOSAGE & ADMINISTRATION • Adults (17 years and older): o Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily ( 2.1 ) o Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 50 mg twice daily ( 2.1 ) o Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily ( 2.1 ) • Pediatric Patients 1 month to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily ( 2.1 ) • Increase dosage based on clinical response and tolerability, no more frequently than once per week ( 2.1 ) • Dose adjustment is recommended for severe renal impairment ( 2.4 , 12.3 ) • Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended ( 2.5 , 12.3 ) 2.1 Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in patients 1 month of age and older and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 4 years of age and older is included in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1. Table 1: Recommended Dosages for Partial-Onset Seizures (Monotherapy or Adjunctive Therapy) in Patients 1 Month and Older, and for Primary Generalized Tonic-Clonic Seizures (Adjunctive Therapy) in Patients 4 Years of Age and Older* Age and Body Weight Initial Dosage Titration Regimen Maintenance Dosage Adults (17 years and older) Monotherapy**: 100 mg twice daily (200 mg per day) Adjunctive Therapy: 50 mg twice daily (100 mg per day) Increase by 50 mg twice daily (100 mg per day) every week Monotherapy**: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) Pediatric patients weighing at least 50 kg 50 mg twice daily (100 mg per day) Increase by 50 mg twice daily (100 mg per day) every week Monotherapy**: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) Pediatric patients weighing 30 kg to less than 50 kg 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 2 mg/kg to 4 mg/kg twice daily (4 mg/kg/day to 8 mg/kg/day) Pediatric patients weighing 11 kg to less than 30 kg 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 3 mg/kg to 6 mg/kg twice daily (6 mg/kg/day to 12 mg/kg/day) Pediatric patients weighing 6 kg to less than 11 kg± Pediatric patients weighing less than 6 kg± 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 3.75 mg/kg to 7.5 mg/kg twice daily (7.5 mg/kg/day to 15 mg/kg/day) * when not specified, the dosage is the same for monotherapy for partial-onset seizures and adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures. ** Monotherapy for partial-onset seizures only ± indicated only for partial-onset seizures In adjunctive clinical trials in adult patients with partial-onset seizures, a dosage higher than 200 mg twice daily (400 mg per day) was not more effective and was associated with a substantially higher rate of adverse reactions [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.2 )] . 2.2 Alternate Initial Dosage Information to Achieve the Maintenance Dosage in a Shorter Timeframe For monotherapy and adjunctive therapy for partial-onset seizures in patients 17 years of age and older and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 17 years of age and older, an alternate initial dosing regimen for week 1 (e.g., including a loading dose"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}