Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03603288 · ClinicalTrials.gov registry record · Phase 3
Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)
A Phase 3 study, sponsored by Santhera Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
NCT03603288: Clinical Trial Phase 3 study, sponsored by Santhera Pharmaceuticals.
NCT03603288 is a Phase 3 study that was terminated before completion, run by Santhera Pharmaceuticals. The registered enrollment target is 161 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03603288, a Phase 3 study, was terminated before completion, sponsored by Santhera Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.
Primary Outcome
To assess the long-term safety of idebenone in DMD patients who completed the SIDEROS study.
Interventions
- DRUG idebenone 150 mg film-coated tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2018-07-04 |
| Est. Completion | 2020-11-25 |
| Phase | Phase 3 |
Why NCT03603288 stopped before completion
NCT03603288 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which idebenone 150 mg film-coated tablets is the first listed.
NCT03603288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03603288 about?
NCT03603288 is a clinical study titled "Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)". The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.
What is the current status of trial NCT03603288?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2018-07-04. Estimated completion is 2020-11-25.
What interventions are being tested in trial NCT03603288?
The interventions under investigation include: idebenone 150 mg film-coated tablets (DRUG).
Who is sponsoring clinical trial NCT03603288?
This trial is sponsored by Santhera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03603288's enrollment target sits among peer trials
161 1478th of 2000 higher than 522 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06391034 · 161 participants · Phase 2
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
- NCT06546670 · 161 participants · Phase 1
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
- NCT06616766 · 161 participants · Phase 1
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
- NCT06752356 · 161 participants · Phase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI