{"id":"levodopa-carbidopa-entacapone","safety":{"commonSideEffects":[{"rate":null,"effect":"Dyskinesia"},{"rate":null,"effect":"Motor fluctuations"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Orthostatic hypotension"},{"rate":null,"effect":"Hallucinations"},{"rate":null,"effect":"Urine discoloration"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Levodopa crosses the blood-brain barrier and is converted to dopamine, the neurotransmitter deficient in Parkinson's disease. Carbidopa is a decarboxylase inhibitor that prevents levodopa's conversion to dopamine in the periphery, allowing more to reach the brain and reducing side effects. Entacapone inhibits COMT, an enzyme that metabolizes dopamine, thereby prolonging levodopa's therapeutic effect and reducing motor fluctuations.","oneSentence":"Levodopa is converted to dopamine in the brain to restore dopamine levels, while carbidopa blocks its peripheral conversion and entacapone inhibits catechol-O-methyltransferase to extend levodopa's duration of action.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:34:04.755Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Carbidopa%2Flevodopa%2Fentacapone","title":"Carbidopa/levodopa/entacapone","extract":"Carbidopa/levodopa/entacapone, sold under the brand name Stalevo among others, is a dopaminergic fixed-dose combination medication that contains carbidopa, an inhibitor of aromatic amino acid decarboxylation; levodopa, an aromatic amino acid; and entacapone, an inhibitor of catechol-O-methyltransferase for the treatment of Parkinson's disease."},"indications":{"approved":[{"name":"Parkinson's disease"}]},"trialDetails":[{"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},{"nctId":"NCT07313176","phase":"","title":"Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease","status":"RECRUITING","sponsor":"Britannia Pharmaceuticals Ltd.","startDate":"2026-01","conditions":"Advanced Parkinson Disease","enrollment":215},{"nctId":"NCT05043103","phase":"","title":"Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Britannia Pharmaceuticals Ltd.","startDate":"2021-07-06","conditions":"Advanced Parkinson Disease","enrollment":312},{"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","enrollment":120},{"nctId":"NCT02096601","phase":"PHASE1","title":"A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2014-08-11","conditions":"Parkinson's Disease","enrollment":16},{"nctId":"NCT06236230","phase":"PHASE4","title":"Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease","status":"UNKNOWN","sponsor":"Second Affiliated Hospital of Soochow University","startDate":"2023-11-15","conditions":"Parkinson Disease","enrollment":60},{"nctId":"NCT06180720","phase":"PHASE1","title":"Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects","status":"UNKNOWN","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2023-12-20","conditions":"Healthy","enrollment":36},{"nctId":"NCT06115538","phase":"PHASE4","title":"Comparison of Dopamin Level in Idiopathic Parkinson's Patients","status":"UNKNOWN","sponsor":"Ankara Ataturk Sanatorium Training and Research Hospital","startDate":"2023-10-01","conditions":"Parkinson Disease, Treatment Adherence","enrollment":96},{"nctId":"NCT05976737","phase":"PHASE1","title":"Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in Healthy Chinese Subjects","status":"UNKNOWN","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2023-08-17","conditions":"Healthy","enrollment":68},{"nctId":"NCT04952194","phase":"PHASE4","title":"Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2022-01-01","conditions":"Parkinson Disease","enrollment":180},{"nctId":"NCT00537017","phase":"PHASE2","title":"Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-11-23","conditions":"Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases","enrollment":140},{"nctId":"NCT01130493","phase":"PHASE3","title":"A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2010-05","conditions":"Parkinson's Disease","enrollment":110},{"nctId":"NCT00406029","phase":"PHASE2","title":"Dyskinesia in Parkinson's Disease (Study P04501)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-11-20","conditions":"Parkinson Disease, Movement Disorders, Central Nervous System Diseases","enrollment":253},{"nctId":"NCT01468012","phase":"PHASE2, PHASE3","title":"Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2014-07","conditions":"Cocaine Dependence","enrollment":23},{"nctId":"NCT01437293","phase":"PHASE1","title":"Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2010-08","conditions":"Cocaine Abuse","enrollment":15},{"nctId":"NCT02764125","phase":"PHASE2","title":"Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2016-04-08","conditions":"Parkinson's Disease","enrollment":84},{"nctId":"NCT00134966","phase":"PHASE3","title":"A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-08","conditions":"Parkinson's Disease","enrollment":493},{"nctId":"NCT03103399","phase":"PHASE2","title":"Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With \"Wearingoff\" Phenomenon","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2006-09-26","conditions":"Parkinson Disease","enrollment":254},{"nctId":"NCT00219284","phase":"PHASE4","title":"Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-01","conditions":"Parkinson's Disease With End of Dose Wearing Off","enrollment":359},{"nctId":"NCT00143026","phase":"PHASE4","title":"Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-07","conditions":"Parkinson's Disease","enrollment":184},{"nctId":"NCT03091868","phase":"PHASE1","title":"Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2004-11-03","conditions":"Parkinson Disease","enrollment":80},{"nctId":"NCT02170376","phase":"PHASE1","title":"The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2011-09","conditions":"Parkinson's Disease (PD)","enrollment":80},{"nctId":"NCT02834507","phase":"PHASE2","title":"Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2005-03","conditions":"Parkinson's Disease (PD)","enrollment":19},{"nctId":"NCT02452606","phase":"NA","title":"Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease","status":"UNKNOWN","sponsor":"Asan Medical Center","startDate":"2015-03","conditions":"Parkinson Disease, Sleep Disorders","enrollment":100},{"nctId":"NCT02448914","phase":"PHASE1","title":"A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients","status":"COMPLETED","sponsor":"LobSor Pharmaceuticals AB","startDate":"2015-05","conditions":"Parkinson's Disease","enrollment":11},{"nctId":"NCT02554734","phase":"PHASE1","title":"Pharmacokinetic Study in Healthy Volunteers","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2015-08","conditions":"Parkinson's Disease","enrollment":15},{"nctId":"NCT01568073","phase":"PHASE3","title":"Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With \"Wearing-off\" Phenomenon","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2011-03","conditions":"Parkinson's Disease","enrollment":600},{"nctId":"NCT01519284","phase":"PHASE1","title":"Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2009-11","conditions":"Parkinson Disease","enrollment":82},{"nctId":"NCT01840423","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2013-05","conditions":"Healthy","enrollment":101},{"nctId":"NCT01688089","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2012-09","conditions":"Healthy","enrollment":67},{"nctId":"NCT01766258","phase":"PHASE2","title":"Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2011-05","conditions":"Parkinson's Disease","enrollment":117},{"nctId":"NCT00601978","phase":"PHASE4","title":"Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2008-08","conditions":"Parkinson's Disease","enrollment":""},{"nctId":"NCT00099268","phase":"PHASE3","title":"Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2004-09","conditions":"Parkinson's Disease","enrollment":747},{"nctId":"NCT01296464","phase":"PHASE2","title":"Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2011-02","conditions":"Parkinson's Disease","enrollment":27},{"nctId":"NCT00491998","phase":"PHASE1, PHASE2","title":"PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets","status":"COMPLETED","sponsor":"Vernalis (R&D) Ltd","startDate":"2006-11","conditions":"Parkinson's Disease","enrollment":27},{"nctId":"NCT00391898","phase":"PHASE4","title":"Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-10","conditions":"Parkinson's Disease","enrollment":95},{"nctId":"NCT00642356","phase":"PHASE4","title":"Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off","status":"TERMINATED","sponsor":"Novartis","startDate":"2008-03","conditions":"Parkinson's Disease","enrollment":14},{"nctId":"NCT01070628","phase":"PHASE1","title":"Levodopa Concentration Profile With Stalevo 75/125 mg","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2009-12","conditions":"Parkinson's Disease","enrollment":20},{"nctId":"NCT00906828","phase":"PHASE4","title":"Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors","status":"COMPLETED","sponsor":"Uppsala University","startDate":"2008-10","conditions":"Parkinson Disease","enrollment":10},{"nctId":"NCT00125567","phase":"PHASE4","title":"Stalevo in Early Wearing-Off Patients","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2005-08","conditions":"Idiopathic Parkinson's Disease","enrollment":223},{"nctId":"NCT00562198","phase":"PHASE2","title":"PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding","status":"TERMINATED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2008-01","conditions":"Parkinson´s Disease","enrollment":16},{"nctId":"NCT00693862","phase":"PHASE1","title":"Pharmacokinetic Study With Repeated Doses of Stalevo","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2006-12","conditions":"Pharmacokinetics","enrollment":19},{"nctId":"NCT00200447","phase":"PHASE2","title":"An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)","status":"COMPLETED","sponsor":"Molecular NeuroImaging","startDate":"2004-03","conditions":"Parkinson's Disease","enrollment":3},{"nctId":"NCT00415740","phase":"PHASE1","title":"Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-05","conditions":"Healthy","enrollment":42},{"nctId":"NCT00415922","phase":"PHASE1","title":"Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-07","conditions":"Healthy","enrollment":42},{"nctId":"NCT00415844","phase":"PHASE1","title":"Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-06","conditions":"Healthy","enrollment":42},{"nctId":"NCT00415831","phase":"PHASE1","title":"Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-06","conditions":"Healthy","enrollment":42}],"_emaApprovals":[],"_faersSignals":[{"count":23,"reaction":"FALL"},{"count":21,"reaction":"DRUG INEFFECTIVE"},{"count":21,"reaction":"DYSKINESIA"},{"count":20,"reaction":"PARKINSON^S DISEASE"},{"count":14,"reaction":"HALLUCINATION, VISUAL"},{"count":13,"reaction":"GAIT DISTURBANCE"},{"count":13,"reaction":"WEIGHT DECREASED"},{"count":12,"reaction":"MOBILITY DECREASED"},{"count":12,"reaction":"ON AND OFF PHENOMENON"},{"count":12,"reaction":"PNEUMONIA"}],"_approvalHistory":[],"publicationCount":85,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Stalevo"],"phase":"marketed","status":"active","brandName":"Levodopa/carbidopa/entacapone","genericName":"Levodopa/carbidopa/entacapone","companyName":"Novartis","companyId":"novartis","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Levodopa/carbidopa/entacapone, sold under the brand name Stalevo, is a medication used to treat Parkinson's disease. It contains carbidopa, which inhibits aromatic amino acid decarboxylation, levodopa, an aromatic amino acid, and entacapone, an inhibitor of catechol-O-methyltransferase.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}