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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 is a Phase 3 study that was terminated before completion, run by Santhera Pharmaceuticals. The registered enrollment target is 161 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03603288
The ClinicalTrials.gov registry entry for NCT03603288 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santhera Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which idebenone 150 mg film-coated tablets is the first listed.
NCT03603288 reports 0 study locations.
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.
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