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NCT02814019 · ClinicalTrials.gov registry record · Phase 3
A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids
A Phase 3 study, sponsored by Santhera Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
NCT02814019: Clinical Trial Phase 3 study, sponsored by Santhera Pharmaceuticals.
NCT02814019 is a Phase 3 study that was terminated before completion, run by Santhera Pharmaceuticals. The registered enrollment target is 255 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02814019, a Phase 3 study, was terminated before completion, sponsored by Santhera Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids
Primary Outcome
Delaying the loss of respiratory function in patients with DMD receiving glucocorticoid steroids as measured by changes in FVC %p from Baseline to Week 78 using hospital based spirometry.
Interventions
- DRUG placebo
- DRUG Idebenone 150 mg film-coated tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2016-09 |
| Est. Completion | 2020-12-01 |
| Phase | Phase 3 |
Why NCT02814019 stopped before completion
NCT02814019 is an interventional study that assigns participants to a tested intervention. The registered 255 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 (67% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02814019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02814019 about?
NCT02814019 is a clinical study titled "A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids". The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids
What is the current status of trial NCT02814019?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2016-09. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT02814019?
The interventions under investigation include: placebo (DRUG), Idebenone 150 mg film-coated tablets (DRUG).
Who is sponsoring clinical trial NCT02814019?
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 NCT02814019's enrollment target sits among peer trials
255 1242nd of 2000 higher than 756 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
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