9 completed, 3 terminated, 1 approved for marketing, 1 no longer available. 6 Phase 2, 6 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Terminated 2 |
| Phase 3 | 6 | Completed 5, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT Vamorolone - Duchenne Muscular Dystrophy | Recruiting | Catalyst Pharmaceuticals, Inc. | 250 | 2024-09-25 | 2026-09-24 | |
| 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 |
| A Safety, Tolerability and Pharmacokinetic Study of CPP-115 CPP-115, Placebo - Cocaine Dependency | Phase 1 | Completed | Catalyst Pharmaceuticals, Inc. | 55 | 2011-12-01 | 2021-04-20 |
| 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 |
| Vigabatrin for the Treatment of Cocaine Dependency Vigabatrin, Matching Placebo - Cocaine Addiction, Cocaine Dependence | Phase 2 / Phase 3 | Completed | Catalyst Pharmaceuticals, Inc. | 207 | 2011-01-01 | 2016-05-18 |
| Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence CPP-109 vigabatrin, Matching Placebo - Methamphetamine Dependence | Phase 2 | Terminated | Catalyst Pharmaceuticals, Inc. | 55 | 2008-07-01 | 2020-12-09 |
| Vigabatrin for Treatment of Cocaine Dependence vigabatrin, placebo - Cocaine Dependence | Phase 2 | Completed | Catalyst Pharmaceuticals, Inc. | 186 | 2008-01-01 | 2016-04-13 |
| Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence Vigabatrin, Placebo, Group therapy - Cocaine Dependence | Phase 2 | Completed | NYU Langone Health | 100 | 2007-04-01 | 2008-04-11 |
| Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome Amifampridine Phosphate - Congenital Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome | Approved for marketing | Catalyst Pharmaceuticals, Inc. | 2025-03-26 | |||
| Treatment Use of 3,4 Diaminopyridine in Congenital Myasthenia 3,4-Diaminopyridine - Congenital Myasthenic Syndrome | No longer available | Ricardo Maselli | 2023-06-02 |
Behavior, Addictive (3) · Cocaine-Related Disorders (3) · Lambert-Eaton Myasthenic Syndrome (3) · Myasthenic Syndromes, Congenital (3) · Myasthenia Gravis (2) · Muscular Atrophy, Spinal (1) · Muscular Dystrophies (1) · Muscular Dystrophy, Duchenne (1) · Nystagmus, Pathologic (1) · Spinal Muscular Atrophies of Childhood (1)
Amifampridine (9) · Vigabatrin (4) · (1S,3S)-3-amino-4-difluoromethylenecyclopentanecarboxylic acid (1) · Psychotherapy, Group (1) · Tablets (1) · VBP15 compound (1)
United States (12) · Italy (3) · France (1) · Germany (1) · Hungary (1) · Mexico (1) · Poland (1) · Puerto Rico (1) · Russia (1) · Serbia (1) · Spain (1)
Charles W Gorodetzky, MD, PhD (2) · Lorenzo Maggi, MD (2) · Perry Shieh, MD, PhD (2) · Renato Mantegazza, MD (2) · Aravindham Veerapandiyan, MD (1) · Christopher J Stock, PharmD (1) · Emilia Figueroa, M.D. (1) · Eugene Somoza, MD, PhD (1) · Jonathan D Brodie, Ph.D., M.D. (1) · Kathleen Brady, MD, PhD (1) · Mardik Donikyan, DO (1) · Ricardo Maselli, MD (1) · Thomas Crawford, M.D. (1) · William Andrews, MD (1)