12 completed, 6 no longer available, 2 approved for marketing, 2 terminated. 8 Phase 3, 6 Phase 2, 1 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 6, Terminated 1, Unknown 1 |
| Phase 2 | 6 | Completed 5, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 1 |
Follow Amifampridine: new trials by email Literature Review of Amifampridine trials Research Report on Amifampridine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA Amifampridine - Botulism, Iatrogenic Botulism | Phase 1 | Completed | Wake Forest University Health Sciences | 21 | 2023-09-15 | 2025-02-03 |
| Pyridostigmine and Amifampridine for Myasthenia Gravis Pyridostigmine, Amifampridine (base) with modified release, Placebo - Myasthenia Gravis | Phase 3 | Unknown | Leiden University Medical Center | 24 | 2023-03-22 | 2023-06-26 |
| Firdapse for Post-BOTOX Vocal Weakness Amifampridine - Vocal Weakness(Post-BOTOX Injection) | Phase 2 | Completed | Augusta University | 18 | 2021-10-28 | 2025-10-03 |
| Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3 Amifampridine Phosphate 10 MG Oral Tablet - Spinal Muscular Atrophy Type 3 | Phase 2 | Terminated | Catalyst Pharmaceuticals, Inc. | 13 | 2019-03-07 | 2023-11-30 |
| Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients Amifampridine Phosphate, Placebo Oral Tablet - Muscular Atrophy, Spinal | Phase 2 | Completed | Catalyst Pharmaceuticals, Inc. | 13 | 2019-01-21 | 2021-06-01 |
| Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) Amifampridine Phosphate - Myasthenia Gravis, MuSK, AChR Myasthenia Gravis | Phase 3 | Terminated | Catalyst Pharmaceuticals, Inc. | 63 | 2018-06-11 | 2024-05-07 |
| Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG Amifampridine Phosphate, Placebo Oral Tablet - Myasthenia Gravis, Generalized | Phase 3 | Completed | Catalyst Pharmaceuticals, Inc. | 93 | 2018-04-18 | 2024-03-12 |
| Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS) Amifampridine Phosphate, Placebo Oral Tablet - Lambert-Eaton Myasthenic Syndrome | Phase 3 | Completed | Catalyst Pharmaceuticals, Inc. | 26 | 2016-11-01 | 2018-12-24 |
| Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes amifampridine phosphate, Placebo - Myasthenic Syndromes, Congenital | Phase 3 | Completed | Catalyst Pharmaceuticals, Inc. | 20 | 2016-01-01 | 2021-04-02 |
| Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome Continuous 3,4-DAP, Taper 3,4-DAP to Placebo - Lambert-Eaton Myasthenic Syndrome, Eaton-Lambert Myasthenic Syndrome | Phase 2 | Completed | Jacobus Pharmaceutical | 32 | 2012-01-01 | 2017-07-11 |
| Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism 3,4-diaminopyridine - Botulism | Phase 2 / Phase 3 | Completed | Centre Hospitalier Universitaire, Amiens | 3 | 2011-09-01 | 2025-09-19 |
| A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS) Amifampridine Phosphate, Placebo - Lambert Eaton Myasthenic Syndrome | Phase 3 | Completed | Catalyst Pharmaceuticals, Inc. | 38 | 2011-06-01 | 2018-01-04 |
| Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation 3,4-diaminopyridine, Placebo - Multiple Sclerosis, Fatigue | Phase 2 | Completed | University of Aarhus | 120 | 2006-06-01 | 2007-12-17 |
| Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP 3,4-diaminopyridine - Lambert Eaton Myasthenic Syndrome (LEMS) | No longer available | Louis H. Weimer, MD | 2005-05-01 | 2013-07-18 | ||
| Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis 3,4-diaminopyridine - Multiple Sclerosis | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 126 | 2005-02-01 | 2011-02-21 |
| Randomized Study of 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome 3,4-diaminopyridine - Lambert-Eaton Myasthenic Syndrome | Not applicable | Completed | FDA Office of Orphan Products Development | 26 | 1994-08-01 | 2015-03-25 |
| Treatment Use of 3,4-Diaminopyridine 3,4-diaminopyridine - Myasthenic Syndromes, Congenital | No longer available | Vern C. Juel, M.D. | 2025-01-20 | |||
| Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine 3,4 diaminopyridine - Lambert-Eaton Myasthenic Syndrome | No longer available | David Lacomis, MD | 2019-07-09 | |||
| 3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS) 3,4-DIAMINOPYRIDINE - Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome | Approved for marketing | Lahey Clinic | 2022-04-11 | |||
| 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM) 3,4-diaminopyridine - Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenia (CM) | No longer available | Oregon Health and Science University | 2019-12-11 |
Showing 20 of 23. Sign in to see all of them.
Lambert-Eaton Myasthenic Syndrome (10) · Myasthenic Syndromes, Congenital (6) · Myasthenia Gravis (3) · Botulism (2) · Fatigue (2) · Multiple Sclerosis (2) · Dysphonia (1) · Mental Disorders (1) · Muscular Atrophy, Spinal (1) · Neurologic Manifestations (1) · Nystagmus, Pathologic (1) · Rare Diseases (1) · Spinal Muscular Atrophies of Childhood (1)
Catalyst Pharmaceuticals, Inc. (8) · Assistance Publique - Hôpitaux de Paris (1) · Augusta University (1) · Centre Hospitalier Universitaire, Amiens (1) · David Lacomis, MD (1) · David P. Richman, MD (1) · FDA Office of Orphan Products Development (1) · Jacobus Pharmaceutical (1) · Lahey Clinic (1) · Leiden University Medical Center (1) · Louis H. Weimer, MD (1) · Oregon Health and Science University (1) · Ricardo Maselli (1) · University of Aarhus (1) · Vern C. Juel, M.D. (1)
United States (15) · France (3) · Italy (3) · Denmark (1) · Germany (1) · Hungary (1) · Netherlands (1) · Poland (1) · Russia (1) · Serbia (1) · Spain (1)
Lorenzo Maggi, MD (2) · Perry Shieh, MD, PhD (2) · Renato Mantegazza, MD (2) · Charles W Gorodetzky, MD, PhD (1) · David Richman, MD (1) · Donald B. Sanders (1) · Henning Andersen, MD, DMSc (1) · James B Caress, MD (1) · Jayashri Srinivasan, MD,MCRP,PhD (1) · Johannes Jacobsen, Professor (1) · Louis H Weimer, MD (1) · Michael H Rivner, MD (1) · Pierre Cesaro, MD (1)
PMID 24007658, PMID 29280483, PMID 35763114, PMID 41945880, PMID 41945881