8 completed, 1 unknown. 9 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 8, Unknown 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 |
|---|---|---|---|---|---|---|
| A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD) Vamorolone, Placebo - Becker Muscular Dystrophy | Phase 2 | Completed | ReveraGen BioPharma, Inc. | 46 | 2022-07-07 | 2026-09-15 |
| A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD) Vamorolone - Duchenne Muscular Dystrophy | Phase 2 | Completed | Santhera Pharmaceuticals | 54 | 2022-03-21 | 2025-10-24 |
| Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF POL6014, Placebo - Cystic Fibrosis | Phase 1 / Phase 2 | Completed | Santhera Pharmaceuticals | 32 | 2018-11-08 | 2021-09-28 |
| Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes Idebenone, Placebo - MELAS Syndrome | Phase 2 | Completed | Michio Hirano | 27 | 2009-05-01 | 2016-10-26 |
| Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Idebenone - Duchenne Muscular Dystrophy | Phase 2 | Completed | Santhera Pharmaceuticals | 21 | 2008-09-01 | 2011-06-01 |
| Fipamezole in Neurogenic Orthostatic Hypotension Placebo, Fipamezole - Symptomatic Neurogenic Orthostatic Hypotension (NOH), Parkinson's Disease | Phase 2 | Unknown | Juvantia Pharma Ltd | 24 | 2008-09-01 | 2008-10-01 |
| Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy Idebenone, Placebo - Leber's Hereditary Optic Neuropathy | Phase 2 | Completed | Santhera Pharmaceuticals | 85 | 2007-11-01 | 2013-05-27 |
| Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease fipamezole - Parkinson's Disease | Phase 2 | Completed | Juvantia Pharma Ltd | 180 | 2007-10-01 | 2009-06-03 |
| Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy idebenone, placebo - Duchenne Muscular Dystrophy (DMD) | Phase 2 | Completed | Santhera Pharmaceuticals | 21 | 2005-10-01 | 2011-08-01 |
Muscular Dystrophy, Duchenne (4) · Muscular Dystrophies (2) · Parkinson Disease (2) · Basal Ganglia Diseases (1) · Cystic Fibrosis (1) · Dyskinesias (1) · Hypotension, Orthostatic (1) · MELAS Syndrome (1) · Movement Disorders (1) · Multiple System Atrophy (1) · Olivopontocerebellar Atrophies (1) · Optic Atrophy, Hereditary, Leber (1) · Pure Autonomic Failure (1) · Shy-Drager Syndrome (1) · Striatonigral Degeneration (1)
idebenone (4) · VBP15 compound (2) · fipamezole (2) · Bulk Drugs (1) · lonodelestat (1)
United States (3) · Belgium (2) · Canada (2) · Germany (2) · France (1) · India (1) · Italy (1) · Portugal (1) · United Kingdom (1)
Gunnar Buyse, MD PhD (1) · Jean K Mah, M.D. (1) · Michio Hirano, MD (1) · Olivier Rascol, MD (1) · Paula Clemens, M.D. (1) · Peter A. LeWitt, M.D. (1) · Prof Gunnar Buyse, MD PhD (1) · Prof Patrick F Chinnery, MD (1) · Prof Thomas Klopstock, MD (1)
PMID 21435876, PMID 21788663, PMID 23263355, PMID 41774261, PMID 42139656