{"id":"controlled-release-levodopa-carbidopa","safety":{"commonSideEffects":[{"rate":null,"effect":"Dyskinesia"},{"rate":null,"effect":"Motor fluctuations"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Orthostatic hypotension"},{"rate":null,"effect":"Hallucinations"},{"rate":null,"effect":"Confusion"},{"rate":null,"effect":"Insomnia"}]},"_chembl":{"chemblId":"CHEMBL1200748","moleculeType":"Small molecule","molecularWeight":"244.25"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"In Parkinson's disease, dopamine-producing neurons degenerate, leading to motor symptoms. Levodopa crosses the blood-brain barrier and is converted to dopamine by aromatic amino acid decarboxylase (AADC). Carbidopa is a decarboxylase inhibitor that cannot cross the blood-brain barrier, so it blocks peripheral conversion of levodopa to dopamine, reducing side effects and increasing the amount of levodopa available for central nervous system conversion. The controlled-release formulation extends drug delivery over time to maintain more stable dopamine levels.","oneSentence":"Levodopa is converted to dopamine in the brain to replace deficient neurotransmitter levels, while carbidopa inhibits its premature breakdown in the periphery, allowing more levodopa to reach the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:43:48.093Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Parkinson's disease"},{"name":"Parkinsonism secondary to carbon monoxide poisoning or manganese intoxication"}]},"trialDetails":[{"nctId":"NCT07442591","phase":"PHASE1","title":"A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants","status":"NOT_YET_RECRUITING","sponsor":"Shanghai WD Pharmaceutical Co., Ltd.","startDate":"2026-03","conditions":"Healhty","enrollment":12},{"nctId":"NCT04006210","phase":"PHASE3","title":"Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations","status":"ACTIVE_NOT_RECRUITING","sponsor":"NeuroDerm Ltd.","startDate":"2019-09-30","conditions":"Parkinson's Disease","enrollment":381},{"nctId":"NCT06596876","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations","status":"RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2024-11-06","conditions":"Parkinson's Disease","enrollment":450},{"nctId":"NCT06003608","phase":"","title":"Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Nimble Science Ltd.","startDate":"2024-02-19","conditions":"Parkinson Disease","enrollment":100},{"nctId":"NCT06614153","phase":"PHASE2","title":"Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2023-05-16","conditions":"Parkinson's Disease","enrollment":61},{"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":"NCT04742348","phase":"PHASE4","title":"Research on Translational Outcomes of Alcohol (Project RETRO)","status":"WITHDRAWN","sponsor":"University of Washington","startDate":"2023-02","conditions":"Alcohol Drinking","enrollment":""},{"nctId":"NCT03670953","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2018-11-06","conditions":"Parkinson's Disease (Disorder)","enrollment":630},{"nctId":"NCT05036473","phase":"PHASE2","title":"A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease","status":"UNKNOWN","sponsor":"Shanghai WD Pharmaceutical Co., Ltd.","startDate":"2021-10-12","conditions":"Parkinson Disease","enrollment":40},{"nctId":"NCT00279825","phase":"PHASE2","title":"Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2006-01","conditions":"Idiopathic Parkinson's Disease","enrollment":16},{"nctId":"NCT02605434","phase":"PHASE3","title":"A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients","status":"UNKNOWN","sponsor":"Intec Pharma Ltd.","startDate":"2016-03","conditions":"Parkinson's Disease","enrollment":420},{"nctId":"NCT03576638","phase":"PHASE2","title":"Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients","status":"UNKNOWN","sponsor":"Intec Pharma Ltd.","startDate":"2018-07","conditions":"Parkinson Disease","enrollment":12},{"nctId":"NCT01646255","phase":"PHASE3","title":"Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients","status":"COMPLETED","sponsor":"UCB Pharma","startDate":"2012-07","conditions":"Idiopathic Parkinson's Disease","enrollment":346},{"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":"NCT00363727","phase":"PHASE3","title":"Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-12","conditions":"Parkinson's Disease, Parkinson Disease, Dyskinesias","enrollment":209},{"nctId":"NCT02774564","phase":"PHASE1","title":"Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Carbidopa","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2005-09","conditions":"Parkinson's Disease","enrollment":16},{"nctId":"NCT01568047","phase":"PHASE2","title":"Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2010-02","conditions":"Parkinson's Disease","enrollment":40},{"nctId":"NCT01470859","phase":"NA","title":"The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2011-12","conditions":"Idiopathic Parkinson's Disease","enrollment":30},{"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":"NCT02169479","phase":"PHASE1","title":"Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2008-09","conditions":"Parkinson's Disease (PD)","enrollment":16},{"nctId":"NCT02169453","phase":"PHASE1","title":"Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2008-10","conditions":"Parkinson's Disease (PD)","enrollment":12},{"nctId":"NCT00918177","phase":"PHASE2","title":"An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease","status":"COMPLETED","sponsor":"Intec Pharma Ltd.","startDate":"2009-07","conditions":"Parkinson's Disease","enrollment":72},{"nctId":"NCT01026428","phase":"PHASE1, PHASE2","title":"A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics","status":"COMPLETED","sponsor":"Newron Pharmaceuticals SPA","startDate":"2009-09","conditions":"Idiopathic Parkinson's Disease","enrollment":24},{"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":"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":"NCT00460954","phase":"","title":"A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2007-06","conditions":"Parkinson's Disease","enrollment":20},{"nctId":"NCT00174239","phase":"PHASE4","title":"Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.","status":"TERMINATED","sponsor":"Pfizer","startDate":"2004-07","conditions":"Parkinson Disease","enrollment":220}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"controlled-release levodopa / carbidopa","genericName":"controlled-release levodopa / carbidopa","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Controlled-release levodopa/carbidopa is used to treat Parkinson's Disease, a condition studied in clinical trials. It is a small molecule modality that works by combining levodopa with carbidopa, a substance that helps increase the availability of levodopa in the brain.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}