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NCT01540409 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy
A Phase 2 study, sponsored by Sarepta Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01540409: Completed Phase 2 study, sponsored by Sarepta Therapeutics.
NCT01540409 is a Phase 2 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01540409, a Phase 2 study, has completed, sponsored by Sarepta Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers for DMD and the clinical status of participating DMD subjects.
Primary Outcome
This study used a modified version of the 6MWT test procedure described in American Thoracic Society (ATS) 2002 guidelines, specifically adapted for patients with Duchenne muscular dystrophy. The participant was asked to walk a set course of 25 meters for 6 minutes (timed) and the distance walked in meters was recorded. Increases from baseline in 6MWT distance are indicative of improvement and decreases from baseline indicate worsening. Baseline here corresponds to the baseline in the parent stu
Interventions
- DRUG AVI-4658 (Eteplirsen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-02-27 |
| Est. Completion | 2017-08-16 |
| Phase | Phase 2 |
What the finished NCT01540409 record still lists
NCT01540409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which AVI-4658 (Eteplirsen) is the first listed.
NCT01540409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01540409 about?
NCT01540409 is a clinical study titled "Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy". The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study ...
What is the current status of trial NCT01540409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2012-02-27. Estimated completion is 2017-08-16.
What interventions are being tested in trial NCT01540409?
The interventions under investigation include: AVI-4658 (Eteplirsen) (DRUG).
Who is sponsoring clinical trial NCT01540409?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01540409's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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