{"id":"fampridine","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Impaired renal function disorder","Seizure disorder"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"trials":[],"_chembl":null,"aliases":["dalfampridine","Ampyra","Fampyra","fampridine prolonged-release tablets","BIIB041"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=fampridine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:21:34.876162+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:21:40.406498+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=fampridine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:21:41.017761+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Voltage-gated potassium channel blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:21:42.145068+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL284348/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:21:41.799042+00:00"}},"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"mechanism":{"target":"Voltage-gated potassium channel, Potassium voltage-gated channel subfamily C member 1, Potassium voltage-gated channel subfamily C member 2"},"_scrapedAt":"2026-03-27T23:46:15.749Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"revenueYear":2024,"annualRevenue":400,"revenueSource":"Verified: Biogen 10-K","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:21:43.520947+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Multiple sclerosis","diseaseId":"multiple-sclerosis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07171203","phase":"PHASE1","title":"Neoadjuvant Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2026-06","conditions":"Gastrointestinal Stromal Tumors","enrollment":18},{"nctId":"NCT06596434","phase":"PHASE2","title":"4-Aminopyridine to Treat Skin Burns","status":"RECRUITING","sponsor":"John Elfar","startDate":"2026-01-01","conditions":"Burns, Second Degree Burn, Wounds and Injuries","enrollment":200},{"nctId":"NCT06136728","phase":"PHASE4","title":"Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis","status":"RECRUITING","sponsor":"MGH Institute of Health Professions","startDate":"2024-06-12","conditions":"Multiple Sclerosis","enrollment":48},{"nctId":"NCT06294821","phase":"PHASE2","title":"4AP for Carpal Tunnel Syndrome (CTS)","status":"NOT_YET_RECRUITING","sponsor":"John Elfar","startDate":"2026-11","conditions":"Compression Neuropathy, Carpal Tunnel Syndrome","enrollment":160},{"nctId":"NCT03701581","phase":"PHASE2, PHASE3","title":"4-aminopyridine Treatment for Nerve Injury","status":"RECRUITING","sponsor":"John Elfar","startDate":"2021-06-05","conditions":"Nerve Injury, Prostate Cancer","enrollment":70},{"nctId":"NCT06751784","phase":"PHASE2","title":"Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression","status":"RECRUITING","sponsor":"University of Basel","startDate":"2025-05-22","conditions":"Working Memory, Mild to Moderate Depression","enrollment":38},{"nctId":"NCT07185347","phase":"PHASE3","title":"A Randomized, Parallel-arm, Double Blind, Placebo-controlled Study to Assess the Efficacy of Fampridine for Patients With Spinocerebellar Ataxia SCA27B Caused by a GAA Expansion in the FGF14 Gene","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2025-10-21","conditions":"Spinocerebellar Ataxia 27B (SCA27B)","enrollment":70},{"nctId":"NCT05123053","phase":"PHASE2","title":"Firdapse for Post-BOTOX Vocal Weakness","status":"COMPLETED","sponsor":"Augusta University","startDate":"2021-10-28","conditions":"Vocal Weakness(Post-BOTOX Injection)","enrollment":18},{"nctId":"NCT01441557","phase":"PHASE2, PHASE3","title":"Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2011-09","conditions":"Botulism","enrollment":3},{"nctId":"NCT04420468","phase":"","title":"Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2020-06-10","conditions":"COVID-19","enrollment":20},{"nctId":"NCT02868567","phase":"PHASE1","title":"Use of Dalfampridine in Primary Lateral Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hospital for Special Surgery, New York","startDate":"2016-03","conditions":"Motor Neuron Disease, Upper","enrollment":35},{"nctId":"NCT06333171","phase":"PHASE2","title":"4-aminopyridine for Skin Wound Healing","status":"RECRUITING","sponsor":"John Elfar","startDate":"2025-09","conditions":"Wounds, Wound of Skin, Wound Heal","enrollment":150},{"nctId":"NCT06003166","phase":"PHASE2","title":"4-AP Peripheral Nerve Crossover Trial","status":"RECRUITING","sponsor":"University of Arizona","startDate":"2025-04-21","conditions":"Peripheral Nerve Injury, Crush Injury","enrollment":68},{"nctId":"NCT06853015","phase":"PHASE1, PHASE2","title":"Double Dose 4-AP on Functional Recovery After Spinal Cord Injury","status":"RECRUITING","sponsor":"Shirley Ryan AbilityLab","startDate":"2025-02-01","conditions":"SCI - Spinal Cord Injury","enrollment":27},{"nctId":"NCT02189720","phase":"","title":"Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome","status":"APPROVED_FOR_MARKETING","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"","conditions":"Congenital Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome, Nystagmus, Acquired","enrollment":""},{"nctId":"NCT05769478","phase":"PHASE1","title":"Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2023-09-15","conditions":"Botulism, Iatrogenic Botulism","enrollment":21},{"nctId":"NCT01765140","phase":"","title":"Treatment Use of 3,4-Diaminopyridine","status":"NO_LONGER_AVAILABLE","sponsor":"Vern C. Juel, M.D.","startDate":"","conditions":"Myasthenic Syndromes, Congenital","enrollment":""},{"nctId":"NCT04516603","phase":"PHASE2","title":"Influence of Fampridine on Working Memory in Healthy Subjects","status":"WITHDRAWN","sponsor":"Prof. Dominique de Quervain, MD","startDate":"2040-01-01","conditions":"Working Memory","enrollment":""},{"nctId":"NCT05338450","phase":"PHASE3","title":"Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis","status":"RECRUITING","sponsor":"Amsterdam UMC, location VUmc","startDate":"2022-08-30","conditions":"Multiple Sclerosis, Internuclear Ophthalmoplegia","enrollment":80},{"nctId":"NCT01645787","phase":"PHASE2, PHASE3","title":"Short and Long Term Treatment With 4-AP in Ambulatory SMA Patients","status":"COMPLETED","sponsor":"Columbia University","startDate":"2012-06-01","conditions":"Spinal Muscular Atrophy","enrollment":11},{"nctId":"NCT05274477","phase":"NA","title":"Influence of Fampridine on Working Memory in Individuals With Post COVID-19 Condition With Subjective Cognitive Impairment","status":"TERMINATED","sponsor":"Prof. Dominique de Quervain, MD","startDate":"2022-06-28","conditions":"Working Memory, Post-covid-19","enrollment":8},{"nctId":"NCT03578354","phase":"PHASE2","title":"4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine","status":"WITHDRAWN","sponsor":"Massachusetts Eye and Ear Infirmary","startDate":"2019-01","conditions":"Vestibular Migraine, Migraine Disorders, Vestibular Diseases","enrollment":""},{"nctId":"NCT03579966","phase":"PHASE3","title":"Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)","status":"TERMINATED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2018-06-11","conditions":"Myasthenia Gravis, MuSK, AChR Myasthenia Gravis","enrollment":63},{"nctId":"NCT03304054","phase":"PHASE3","title":"Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG","status":"COMPLETED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2018-04-18","conditions":"Myasthenia Gravis, Generalized","enrollment":93},{"nctId":"NCT03819660","phase":"PHASE2","title":"Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3","status":"TERMINATED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2019-03-07","conditions":"Spinal Muscular Atrophy Type 3","enrollment":13},{"nctId":"NCT05919407","phase":"PHASE3","title":"Pyridostigmine and Amifampridine for Myasthenia Gravis","status":"UNKNOWN","sponsor":"Leiden University Medical Center","startDate":"2023-03-22","conditions":"Myasthenia Gravis","enrollment":24},{"nctId":"NCT05447676","phase":"EARLY_PHASE1","title":"Effects of 4-AP on Functional SCI Recovery","status":"UNKNOWN","sponsor":"Shirley Ryan AbilityLab","startDate":"2022-06-30","conditions":"Spinal Cord Injury","enrollment":44},{"nctId":"NCT03062631","phase":"","title":"Treatment Use of 3,4 Diaminopyridine in Congenital Myasthenia","status":"NO_LONGER_AVAILABLE","sponsor":"Ricardo Maselli","startDate":"","conditions":"Congenital Myasthenic Syndrome","enrollment":""},{"nctId":"NCT05859802","phase":"PHASE2, PHASE3","title":"Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis","status":"COMPLETED","sponsor":"D'Youville College","startDate":"2011-07-13","conditions":"Multiple Sclerosis","enrollment":35},{"nctId":"NCT05730738","phase":"NA","title":"Dalfampridine in Egyptian Patients With Multiple Sclerosis","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2021-06-01","conditions":"Multiple Sclerosis","enrollment":100},{"nctId":"NCT04652557","phase":"PHASE2","title":"Influence of Fampridine on Working Memory in Healthy Young Subjects","status":"COMPLETED","sponsor":"Prof. Dominique de Quervain, MD","startDate":"2021-11-01","conditions":"Working Memory","enrollment":44},{"nctId":"NCT05613114","phase":"NA","title":"Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia","status":"COMPLETED","sponsor":"European University of Lefke","startDate":"2020-08-03","conditions":"Hereditary Spastic Paraplegia","enrollment":8},{"nctId":"NCT04026568","phase":"PHASE2, PHASE3","title":"A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma","status":"TERMINATED","sponsor":"Milton S. Hershey Medical Center","startDate":"2021-08-17","conditions":"Nerve Injury","enrollment":1},{"nctId":"NCT04148781","phase":"EARLY_PHASE1","title":"Fampridine-SR and Optic Neuritis Recovery","status":"UNKNOWN","sponsor":"Courtney Casserly","startDate":"2022-03-22","conditions":"Optic Neuritis","enrollment":20},{"nctId":"NCT00872950","phase":"","title":"3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)","status":"APPROVED_FOR_MARKETING","sponsor":"Lahey Clinic","startDate":"","conditions":"Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome","enrollment":""},{"nctId":"NCT03847545","phase":"NA","title":"Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking Technique","status":"COMPLETED","sponsor":"University of Southern Denmark","startDate":"2018-12-12","conditions":"Multiple Sclerosis","enrollment":48},{"nctId":"NCT03401307","phase":"","title":"Central and Peripheral Nervous System Changes as Markers of Disease Progression in Multiple Sclerosis","status":"COMPLETED","sponsor":"University of Southern Denmark","startDate":"2017-08-01","conditions":"Multiple Sclerosis, Neurodegeneration, Central Nervous System Lesion","enrollment":49},{"nctId":"NCT02208050","phase":"PHASE4","title":"A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS","status":"COMPLETED","sponsor":"University College Dublin","startDate":"2014-02-21","conditions":"Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis","enrollment":64},{"nctId":"NCT03781479","phase":"PHASE2","title":"Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients","status":"COMPLETED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2019-01-21","conditions":"Muscular Atrophy, Spinal","enrollment":13},{"nctId":"NCT02562066","phase":"PHASE3","title":"Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes","status":"COMPLETED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2016-01","conditions":"Myasthenic Syndromes, Congenital","enrollment":20},{"nctId":"NCT03899584","phase":"PHASE3","title":"High Doses of 4-aminopyridine in Clinically Complete Chronic Spinal Cord Injury Patients.","status":"UNKNOWN","sponsor":"Coordinación de Investigación en Salud, Mexico","startDate":"2019-07-17","conditions":"Spinal Cord Injuries, Chronic","enrollment":150},{"nctId":"NCT02966808","phase":"","title":"Retrospective Observational Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis","status":"UNKNOWN","sponsor":"Hospital General Universitario Gregorio Marañon","startDate":"2016-12","conditions":"Multiple Sclerosis","enrollment":50},{"nctId":"NCT02849782","phase":"PHASE4","title":"Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine.","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2014-02-04","conditions":"Multiple Sclerosis","enrollment":89},{"nctId":"NCT01543750","phase":"PHASE2","title":"4-Aminopyridine in Episodic Ataxia Type 2","status":"WITHDRAWN","sponsor":"University of California, Los Angeles","startDate":"","conditions":"Episodic Ataxia Type 2","enrollment":""},{"nctId":"NCT02006160","phase":"PHASE2, PHASE3","title":"Effects of Dalfampridine on Cognition in Multiple Sclerosis","status":"COMPLETED","sponsor":"State University of New York at Buffalo","startDate":"2011-12","conditions":"Multiple Sclerosis","enrollment":61},{"nctId":"NCT02391961","phase":"PHASE2","title":"Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2015-04-01","conditions":"Multiple Sclerosis, Internuclear Ophthalmoplegia, Fatigue","enrollment":23},{"nctId":"NCT01337986","phase":"PHASE2, PHASE3","title":"Ampyra for Optic Neuritis in Multiple Sclerosis","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2011-05","conditions":"Multiple Sclerosis, Optic Neuritis","enrollment":53},{"nctId":"NCT00041717","phase":"PHASE3","title":"Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2002-07","conditions":"Spinal Cord Injury, Muscle Spasticity","enrollment":213},{"nctId":"NCT02012933","phase":"","title":"3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM)","status":"NO_LONGER_AVAILABLE","sponsor":"Oregon Health and Science University","startDate":"","conditions":"Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenia (CM)","enrollment":""},{"nctId":"NCT00704925","phase":"","title":"Treatment of Lambert-Eaton Syndrome With 3,4 DAP","status":"NO_LONGER_AVAILABLE","sponsor":"David P. Richman, MD","startDate":"","conditions":"Lambert Eaton Myasthenic Syndrome","enrollment":""},{"nctId":"NCT02280096","phase":"PHASE2","title":"Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis","status":"COMPLETED","sponsor":"Coordinación de Investigación en Salud, Mexico","startDate":"2014-10","conditions":"Multiple Sclerosis","enrollment":24},{"nctId":"NCT00994916","phase":"","title":"Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine","status":"NO_LONGER_AVAILABLE","sponsor":"David Lacomis, MD","startDate":"","conditions":"Lambert-Eaton Myasthenic Syndrome","enrollment":""},{"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":"NCT02146534","phase":"PHASE4","title":"Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients","status":"COMPLETED","sponsor":"Clinique Neuro-Outaouais","startDate":"2013-12","conditions":"Multiple Sclerosis","enrollment":44},{"nctId":"NCT03164018","phase":"","title":"Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis","status":"COMPLETED","sponsor":"Genesis Pharma CNS & Specialty","startDate":"2017-03-07","conditions":"Multiple Sclerosis","enrollment":111},{"nctId":"NCT02422940","phase":"PHASE3","title":"Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.","status":"TERMINATED","sponsor":"Acorda Therapeutics","startDate":"2015-04","conditions":"Post-ischemic Stroke","enrollment":294},{"nctId":"NCT02970162","phase":"PHASE3","title":"Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)","status":"COMPLETED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2016-11","conditions":"Lambert-Eaton Myasthenic Syndrome","enrollment":26},{"nctId":"NCT03658408","phase":"PHASE2","title":"4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy","status":"WITHDRAWN","sponsor":"University of Rochester","startDate":"2018-10-03","conditions":"Prostate Disease","enrollment":""},{"nctId":"NCT01356940","phase":"PHASE4","title":"A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis","status":"COMPLETED","sponsor":"Brown, Theodore R., M.D., MPH","startDate":"2010-11","conditions":"Multiple Sclerosis","enrollment":43},{"nctId":"NCT00127530","phase":"PHASE3","title":"Study of Oral Fampridine-SR in Multiple Sclerosis","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2005-05","conditions":"Multiple Sclerosis","enrollment":300},{"nctId":"NCT01656148","phase":"PHASE4","title":"FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra","status":"COMPLETED","sponsor":"University of Southern Denmark","startDate":"2012-06","conditions":"Multiple Sclerosis","enrollment":108},{"nctId":"NCT02143167","phase":"PHASE4","title":"Resistance Training and Amino Pyridine in Multiple Sclerosis","status":"COMPLETED","sponsor":"University of Southern Denmark","startDate":"2014-05","conditions":"Multiple Sclerosis","enrollment":40},{"nctId":"NCT02271217","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2014-12","conditions":"Post-Ischemic Stroke","enrollment":377},{"nctId":"NCT02166346","phase":"PHASE2","title":"Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2014-02","conditions":"Transverse Myelitis, Neuromyelitis Optica, Idiopathic Transverse Myelitis","enrollment":24},{"nctId":"NCT01377922","phase":"PHASE3","title":"A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)","status":"COMPLETED","sponsor":"Catalyst Pharmaceuticals, Inc.","startDate":"2011-06","conditions":"Lambert Eaton Myasthenic Syndrome","enrollment":38},{"nctId":"NCT01491022","phase":"PHASE1, PHASE2","title":"A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease","status":"COMPLETED","sponsor":"University of Miami","startDate":"2012-07","conditions":"Parkinson's Disease","enrollment":22},{"nctId":"NCT01621113","phase":"PHASE2","title":"Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury","status":"COMPLETED","sponsor":"Kessler Foundation","startDate":"2012-06","conditions":"Spinal Cord Injury","enrollment":27},{"nctId":"NCT01683838","phase":"PHASE3","title":"Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2002-06","conditions":"Spinal Cord Injury, Muscle Spasticity","enrollment":204},{"nctId":"NCT02656160","phase":"PHASE2","title":"Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2016-01","conditions":"Sleep Apnea, Obstructive","enrollment":13},{"nctId":"NCT01511978","phase":"PHASE2","title":"Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome","status":"COMPLETED","sponsor":"Jacobus Pharmaceutical","startDate":"2012-01","conditions":"Lambert-Eaton Myasthenic Syndrome, Eaton-Lambert Myasthenic Syndrome","enrollment":32},{"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":"NCT01547234","phase":"","title":"Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis","status":"COMPLETED","sponsor":"Carmel Medical Center","startDate":"2013-02","conditions":"Multiple Sclerosis","enrollment":47},{"nctId":"NCT00483652","phase":"PHASE3","title":"Study of Fampridine-SR Tablets in Multiple Sclerosis Patients","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2007-05","conditions":"Multiple Sclerosis","enrollment":240},{"nctId":"NCT01975324","phase":"PHASE4","title":"A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)","status":"COMPLETED","sponsor":"Neuro-Ophthalmologic Associates, PC","startDate":"2013-07","conditions":"Non Arteritic Ischemic Optic Neuropathy","enrollment":20},{"nctId":"NCT01605825","phase":"PHASE2","title":"A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2012-05","conditions":"Ischemic Stroke","enrollment":83},{"nctId":"NCT01576354","phase":"PHASE2","title":"Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple Sclerosis","status":"UNKNOWN","sponsor":"University of Zurich","startDate":"2012-03","conditions":"Multiple Sclerosis","enrollment":70},{"nctId":"NCT01399957","phase":"","title":"Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients","status":"COMPLETED","sponsor":"Mount Sinai Rehabilitation Hospital","startDate":"2010-08","conditions":"Multiple Sclerosis","enrollment":52},{"nctId":"NCT01667497","phase":"PHASE2, PHASE3","title":"Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients?","status":"COMPLETED","sponsor":"London Health Sciences Centre","startDate":"2012-09","conditions":"Cognitive Fatigue","enrollment":60},{"nctId":"NCT00056810","phase":"PHASE2","title":"Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine","status":"COMPLETED","sponsor":"FDA Office of Orphan Products Development","startDate":"2002-09","conditions":"Guillain-Barre Syndrome","enrollment":30},{"nctId":"NCT00004832","phase":"NA","title":"Randomized Study of 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome","status":"COMPLETED","sponsor":"FDA Office of Orphan Products Development","startDate":"1994-08","conditions":"Lambert-Eaton Myasthenic Syndrome","enrollment":26},{"nctId":"NCT01811706","phase":"NA","title":"Dalfampridine and Gait in Spinocerebellar Ataxias","status":"COMPLETED","sponsor":"University of Florida","startDate":"2013-02","conditions":"Spinocerebellar Ataxias Type 1, Spinocerebellar Ataxias Type 2, Spinocerebellar Ataxias Type 3","enrollment":20},{"nctId":"NCT02259361","phase":"PHASE4","title":"Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS","status":"UNKNOWN","sponsor":"Sheba Medical Center","startDate":"2014-11","conditions":"Multiple Sclerosis","enrollment":30},{"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},{"nctId":"NCT01468350","phase":"PHASE1","title":"Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2011-12","conditions":"Cerebral Palsy (CP)","enrollment":35},{"nctId":"NCT01444300","phase":"PHASE2","title":"Dalfampridine for Imbalance in Multiple Sclerosis","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2011-09","conditions":"Multiple Sclerosis, Fatigue","enrollment":24},{"nctId":"NCT01535664","phase":"","title":"An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2012-01","conditions":"Multiple Sclerosis","enrollment":20},{"nctId":"NCT01328379","phase":"PHASE3","title":"Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2011-03","conditions":"Multiple Sclerosis","enrollment":430},{"nctId":"NCT01378546","phase":"","title":"Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP","status":"NO_LONGER_AVAILABLE","sponsor":"Louis H. Weimer, MD","startDate":"2005-05","conditions":"Lambert Eaton Myasthenic Syndrome (LEMS)","enrollment":""},{"nctId":"NCT01316055","phase":"PHASE1","title":"Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2011-01","conditions":"Renal Insufficiency","enrollment":42},{"nctId":"NCT00654927","phase":"PHASE3","title":"Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2003-11","conditions":"Multiple Sclerosis","enrollment":177},{"nctId":"NCT00649792","phase":"PHASE3","title":"Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2007-08","conditions":"Multiple Sclerosis","enrollment":214},{"nctId":"NCT00648908","phase":"PHASE3","title":"Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2006-06","conditions":"Multiple Sclerosis","enrollment":269},{"nctId":"NCT00053417","phase":"PHASE2","title":"Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis","status":"COMPLETED","sponsor":"Acorda Therapeutics","startDate":"2003-02","conditions":"Multiple Sclerosis","enrollment":206},{"nctId":"NCT00190268","phase":"PHASE3","title":"Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2005-02","conditions":"Multiple Sclerosis","enrollment":126},{"nctId":"NCT00342381","phase":"PHASE2","title":"Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2006-06","conditions":"Multiple Sclerosis, Fatigue","enrollment":120}],"_emaApprovals":[],"_faersSignals":[{"count":82,"reaction":"FATIGUE"},{"count":69,"reaction":"FALL"},{"count":69,"reaction":"GAIT DISTURBANCE"},{"count":63,"reaction":"ASTHENIA"},{"count":55,"reaction":"MULTIPLE SCLEROSIS RELAPSE"},{"count":51,"reaction":"DIZZINESS"},{"count":48,"reaction":"HEADACHE"},{"count":48,"reaction":"URINARY TRACT INFECTION"},{"count":47,"reaction":"NAUSEA"},{"count":45,"reaction":"HYPOAESTHESIA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL284348"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":221,"therapeuticAreas":["Neuroscience"],"_revenueScrapedAt":"2026-04-08 13:57:54.990037+00","biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"fampridine","genericName":"fampridine","companyName":"Biogen","companyId":"biogen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"AU","regulator":"TGA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"CH","regulator":"Swissmedic","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"NO","regulator":"NoMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"IS","regulator":"IMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"NZ","regulator":"Medsafe","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"BG","regulator":"BDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"AT","regulator":"AGES","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"BE","regulator":"FAMHP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":"EMEA/H/C/002097"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"HR","regulator":"HALMED","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"CY","regulator":"PHS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"CZ","regulator":"SUKL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"DK","regulator":"DKMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"EE","regulator":"SAM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"FI","regulator":"Fimea","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"FR","regulator":"ANSM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"DE","regulator":"BfArM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"GR","regulator":"EOF","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"HU","regulator":"OGYEI","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"IE","regulator":"HPRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"IT","regulator":"AIFA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"LV","regulator":"ZVA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"LT","regulator":"VVKT","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"LU","regulator":"MS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"MT","regulator":"MMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"NL","regulator":"MEB","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"PL","regulator":"URPL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"PT","regulator":"Infarmed","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"RO","regulator":"ANMDMR","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"SK","regulator":"SIDC","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"SI","regulator":"JAZMP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"ES","regulator":"AEMPS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"SE","regulator":"MPA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Fampyra","application_number":null},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:21:43.520947+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}