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Clinical trials
catalyst calendar across sponsors →Studies where CPRX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
11 interventional · 1 observational · 1 expanded access · 11 with posted results
Held by 17 tracked-famous managers (Qube Research & Technologies Ltd, RENAISSANCE TECHNOLOGIES LLC, MILLENNIUM MANAGEMENT LLC, MARSHALL WACE, LLP, SOROS FUND MANAGEMENT LLC, +12 more) · FINRA short interest 1.0 days to cover (settled 2026-07-15) · government filings 180d: 0 congress / 1 executive
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMITNCT06564974observationalChange in Height z-score | — | Recruiting | Drug: Vamorolone | Duchenne Muscular Dystrophy | 250 | Feb 2032 | ≤ 2,020 d | 2026-07-20 |
| Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)NCT03579966results2024-05-07Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)Open-label · TreatmentStudy Protocol: Original Protocol ↗ · Study Protocol: Amendment 1 ↗ · Statistical Analysis Plan: Version 1 PBRS ↗ · Statistical Analysis Plan: Version 1 StatKing ↗ · Statistical Analysis Plan: version 2.0 PBRS ↗ | Phase 3 | Terminatedsponsor's stated reason: Lack of measure appropriate data (MG-ADL). | Drug: Amifampridine Phosphate | Myasthenia Gravis, MuSK, AChR Myasthenia Gravis | 63 | 2022-08-05actual | — | 2024-05-07 |
| Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3NCT03819660results2023-11-30Long-term Safety and Tolerability of AmifampridineOpen-label · TreatmentStudy Protocol: original protocol ↗ · Study Protocol: Amendment 1 ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Development of indication not being pursued | Drug: Amifampridine Phosphate 10 MG Oral Tablet | Spinal Muscular Atrophy Type 3 | 13 | 2021-09-13actual | — | 2023-11-30 |
| Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 PatientsNCT03781479results2021-06-01Hammersmith Functional Motor Scale Expanded (HFMSE) Summary Statistics and Mixed Model AnalysisRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Amifampridine Phosphate, Placebo Oral Tablet | Muscular Atrophy, Spinal | 13 | 2020-07-23actual | — | 2021-06-01 |
| Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MGNCT03304054results2021-08-13Myasthenia Gravis-Activities of Daily Living (MG-ADL) Summary by Time Point and Myasthenia Gravis Type: Wilcoxon-Mann-Whitney Rank Sum Test ResultsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Amifampridine Phosphate, Placebo Oral Tablet | Myasthenia Gravis, Generalized | 93 | 2020-01-31actual | — | 2024-03-12 |
| Amifampridine Phosphate for the Treatment of Congenital Myasthenic SyndromesNCT02562066results2021-04-02Subject Global Impression (SGI) Score Summary: Mann-Whitney Main Effects Test Results; SGI Score Mixed Model AnalysisRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: amifampridine phosphate, Placebo | Myasthenic Syndromes, Congenital | 20 | Aug 2019actual | — | 2021-04-02 |
| Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)NCT02970162results2018-12-24Quantitative Myasthenia Gravis (QMG) ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Amifampridine Phosphate, Placebo Oral Tablet | Lambert-Eaton Myasthenic Syndrome | 26 | Oct 2017actual | — | 2018-12-24 |
| A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)NCT01377922results2018-01-04Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 DaysRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Amifampridine Phosphate, Placebo | Lambert Eaton Myasthenic Syndrome | 38 | Jul 2016actual | — | 2018-01-04 |
| Vigabatrin for the Treatment of Cocaine DependencyNCT01281202results2016-02-23AbstinenceRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: Vigabatrin, Matching Placebo | Cocaine Addiction, Cocaine Dependence | 207 | Oct 2012actual | — | 2016-05-18 |
| A Safety, Tolerability and Pharmacokinetic Study of CPP-115NCT01493596results2021-04-20Safety of Single Oral DosesRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: CPP-115, Placebo | Cocaine Dependency | 55 | Jun 2012actual | — | 2021-04-20 |
| Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine DependenceNCT00730522results2020-12-09The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12).Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: To conserve remaining capital, Sponsor decided to terminate the study early. | Drug: CPP-109 vigabatrin, Matching Placebo | Methamphetamine Dependence | 55 | Jun 2009actual | — | 2020-12-09 |
| Vigabatrin for Treatment of Cocaine DependenceNCT00611130results2012-06-12Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: vigabatrin, placebo | Cocaine Dependence | 186 | May 2009actual | — | 2016-04-13 |
| Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic SyndromeNCT02189720expanded access | — | Approved for marketing | Drug: Amifampridine Phosphate | Congenital Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome, Nystagmus, Acquired | — | — | — | 2025-03-26 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19