{"id":"biib041-fampridine","safety":{"commonSideEffects":[{"rate":"2-3","effect":"Seizures"},{"rate":"10-15","effect":"Urinary tract infection"},{"rate":"5-10","effect":"Insomnia"},{"rate":"5-10","effect":"Dizziness"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Asthenia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fampridine blocks voltage-gated potassium channels on demyelinated axons, prolonging action potentials and increasing the likelihood of action potential propagation across damaged nerve segments. This mechanism restores conduction in partially demyelinated nerve fibers, leading to improved motor function and walking ability in patients with multiple sclerosis and other demyelinating conditions.","oneSentence":"Fampridine is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in demyelinating diseases.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:21.203Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple sclerosis with gait impairment"},{"name":"Spinal cord injury (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT01480063","phase":"","title":"An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice","status":"COMPLETED","sponsor":"Biogen","startDate":"2012-04-16","conditions":"Multiple Sclerosis","enrollment":4734},{"nctId":"NCT02219932","phase":"PHASE3","title":"Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis","status":"COMPLETED","sponsor":"Biogen","startDate":"2014-09","conditions":"Multiple Sclerosis","enrollment":646},{"nctId":"NCT01917019","phase":"PHASE3","title":"A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis","status":"COMPLETED","sponsor":"Biogen","startDate":"2013-08","conditions":"Multiple Sclerosis, Remittent Progressive, Multiple Sclerosis, Primary Progressive, Relapsing-Remitting Multiple Sclerosis","enrollment":101},{"nctId":"NCT01480076","phase":"PHASE4","title":"Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis","status":"COMPLETED","sponsor":"Biogen","startDate":"2012-02","conditions":"Multiple Sclerosis","enrollment":901},{"nctId":"NCT01597297","phase":"PHASE2","title":"Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.","status":"COMPLETED","sponsor":"Biogen","startDate":"2012-08","conditions":"Multiple Sclerosis","enrollment":132},{"nctId":"NCT01532154","phase":"","title":"Fampridine Pregnancy Exposure Registry","status":"TERMINATED","sponsor":"Biogen","startDate":"2015-08","conditions":"Multiple Sclerosis, Pregnancy","enrollment":1},{"nctId":"NCT01215084","phase":"PHASE1","title":"A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers","status":"COMPLETED","sponsor":"Biogen","startDate":"2010-10","conditions":"Healthy","enrollment":36},{"nctId":"NCT01235221","phase":"PHASE3","title":"Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.","status":"COMPLETED","sponsor":"Biogen","startDate":"2010-12","conditions":"Multiple Sclerosis","enrollment":38}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fampyra","prolonged-release fampridine","dalfampridine","Ampyra"],"phase":"phase_3","status":"active","brandName":"BIIB041 (fampridine)","genericName":"BIIB041 (fampridine)","companyName":"Biogen","companyId":"biogen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fampridine is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in demyelinating diseases. Used for Multiple sclerosis with gait impairment, Spinal cord injury (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}