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NCT03433807
Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)
trial testing Idebenone in Duchenne Muscular Dystrophy. No longer available.
Quick facts
| Lead sponsor | Santhera Pharmaceuticals |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Idebenone (IDEBENONE) — full drug profile →
Conditions studied
- Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →
Sponsor
Santhera Pharmaceuticals — full company profile →
Who can join
8 and older, any sex, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this Expanded Access Program is to provide idebenone as a treatment for eligible participants with Duchenne Muscular Dystrophy before it is commercially available in the United States (U.S.) for the indication of DMD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03433807
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Idebenone
Trials testing the same drug.
- NCT05411978 — Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients · Phase 4 · unknown
- NCT04669158 — Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis · Phase 1, PHASE2 · completed
- NCT04534023 — A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies · Phase 2 · active not recruiting
- NCT04071639 — Symptomatic Therapy for Patients With Huntington's Disease · Phase 1 · unknown
- NCT04152655 — A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease · Phase 2, PHASE3 · withdrawn
Other recruiting trials for Duchenne Muscular Dystrophy
Currently open trials in the same condition.
- NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
- NCT06817382 — A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Ma · Phase 1 · recruiting
- NCT06402942 — Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy · NA · recruiting
- NCT06450639 — A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) · Phase 2 · active not recruiting
- NCT06692426 — Trial of Cell Based Therapy for DMD · Phase 1 · recruiting
Other Santhera Pharmaceuticals trials
Trials by the same sponsor.
- NCT06689527 — Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics · Phase 1 · completed
- NCT06649409 — Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects · Phase 1 · completed
- NCT05185622 — A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD) · Phase 2 · completed
- NCT03748199 — Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF · Phase 1, PHASE2 · completed
- NCT03603288 — Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03433807 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Santhera Pharmaceuticals
- Last refreshed: 21 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03433807.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing