24 completed, 2 no longer available, 2 terminated, 1 active not recruiting. 9 Phase 2, 9 Phase 3, 5 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 8, Unknown 1 |
| Phase 3 | 9 | Completed 6, Terminated 2, Withdrawn 1 |
| Phase 1 | 5 | Completed 5 |
| Phase 4 | 2 | Active not recruiting 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 on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy vamorolone 40 mg/mL oral suspension - Duchenne Muscular Dystrophy | Phase 4 | Active not recruiting | Santhera Pharmaceuticals | 80 | 2024-11-10 | 2026-04-23 |
| Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics Vamorolone, Midazolam - Drug Interaction | Phase 1 | Completed | Santhera Pharmaceuticals | 18 | 2024-08-13 | 2025-12-15 |
| Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects Vamorolone, Eplerenone, Fludrocortisone - Pharmacodynamic | Phase 1 | Completed | Santhera Pharmaceuticals | 30 | 2024-06-05 | 2025-09-11 |
| 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 |
| Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families Duchenne Muscular Dystrophy, Burden, Dependency | Completed | Jett Foundation, Inc. | 60 | 2018-09-20 | 2019-04-01 | |
| Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) idebenone 150 mg film-coated tablets - Duchenne Muscular Dystrophy | Phase 3 | Terminated | Santhera Pharmaceuticals | 161 | 2018-07-04 | 2021-12-03 |
| Post Authorisation Safety Study With Raxone in LHON Patients Idebenone - Leber's Hereditary Optic Neuropathy (LHON) | Completed | Santhera Pharmaceuticals | 229 | 2016-09-01 | 2021-07-16 | |
| A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate Raxone (idebenone 150 mg), Midazolam 2,5 mg - Drug-Drug Interaction | Phase 1 | Completed | Santhera Pharmaceuticals | 32 | 2016-09-01 | 2017-10-05 |
| A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids Idebenone 150 mg film-coated tablets, placebo - Duchenne Muscular Dystrophy (DMD) | Phase 3 | Terminated | Santhera Pharmaceuticals | 255 | 2016-09-01 | 2021-12-03 |
| Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON) Leber's Hereditary Optic Neuropathy (LHON) | Completed | Santhera Pharmaceuticals | 219 | 2016-05-01 | 2020-01-30 | |
| Study to Assess the Efficacy and Safety of Raxone in LHON Patients Idebenone - Leber's Hereditary Optic Neuropathy (LHON) | Phase 4 | Completed | Santhera Pharmaceuticals | 199 | 2016-05-01 | 2023-04-21 |
| Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO) Omigapil - Congenital Muscular Dystrophy | Phase 1 | Completed | Santhera Pharmaceuticals | 20 | 2014-12-01 | 2021-09-24 |
| Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey Leber Hereditary Optic Neuropathy (LHON) | Completed | Santhera Pharmaceuticals | 306 | 2013-08-01 | 2014-05-15 | |
| RHODOS Follow-up Single-visit Study Leber's Hereditary Optic Neuropathy | Completed | Santhera Pharmaceuticals | 60 | 2011-09-01 | 2013-05-27 | |
| Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI) Idebenone, Placebo - Friedreich's Ataxia | Phase 3 | Completed | Santhera Pharmaceuticals | 29 | 2011-04-01 | 2016-03-09 |
| Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) Placebo, Idebenone - Muscular Dystrophy, Duchenne, Ambulatory Care | Phase 3 | Completed | Santhera Pharmaceuticals | 65 | 2009-07-01 | 2015-10-19 |
| 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 |
Showing 20 of 32. Sign in to see all of them.
Muscular Dystrophy, Duchenne (11) · Optic Atrophy, Hereditary, Leber (8) · Friedreich Ataxia (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) · Pure Autonomic Failure (1) · Rare Diseases (1)
idebenone (18) · VBP15 compound (6) · fipamezole (2) · Bulk Drugs (1) · Drug Evaluation (1) · Drugs, Investigational (1) · Eplerenone (1) · Fludrocortisone (1) · Midazolam (1) · Suspensions (1) · Tablets (1) · dibenzo(b,f)oxepin-10-ylmethyl-methyl-prop-2-ynyl-amine (1) · lonodelestat (1)
Germany (14) · United States (13) · Belgium (11) · France (10) · United Kingdom (9) · Austria (8) · Italy (8) · Netherlands (8) · Spain (5) · Canada (4) · Israel (3) · Switzerland (3) · Bulgaria (2) · Greece (2) · Ireland (2)
David Lynch, MD (2) · Nick Wood, Professor (2) · Susan Perlman, MD (2) · Ana Camacho Salas, MD (1) · Ass. Prof. Jan Verschuuren, MD, PhD (1) · Barry Byrne, MD (1) · Bryan W. Burnette, MD (1) · Christine McSherry, R.N. (1) · Craig McDonald, MD (1) · Dr. Pierre-Yves Jeannet, Médecin Associé, MER (1) · Dr. Ulrike Schara, MD, PhD (1) · Ericka Simpson, MD (1) · Gihan Tennekoon, MD (1) · Gunnar Buyse, MD PhD (1)
PMID 21779958, PMID 41774261, PMID 42139656, PMID 20697044, PMID 21392622, PMID 21435876, PMID 21788663, PMID 23263355, PMID 23388409, PMID 25907158, PMID 28189481, PMID 38428428, PMID 38915423, PMID 40957504