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NCT02255552 · ClinicalTrials.gov registry record · Phase 3
Study of Eteplirsen in DMD Patients
A Phase 3 study, sponsored by Sarepta Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
NCT02255552: Completed Phase 3 study, sponsored by Sarepta Therapeutics.
NCT02255552 is a Phase 3 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255552, a Phase 3 study, has completed, sponsored by Sarepta Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
Study Summary
The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the long-term effects of eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).
Primary Outcome
6MWT was performed by standardized procedures for all participants. Participants were asked to walk a set course of 25 meters for 6 minutes (timed), and the distance walked (in meters) was recorded. Change from baseline in 6MWT distance at Week 96 was reported.
Interventions
- DRUG eteplirsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2014-11-17 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 3 |
What the finished NCT02255552 record still lists
NCT02255552 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (86% lower).
The record links to 0 conditions, and to 1 intervention - of which eteplirsen is the first listed.
NCT02255552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02255552 about?
NCT02255552 is a clinical study titled "Study of Eteplirsen in DMD Patients". The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the long-term effects of eteplirsen up to 96 weeks, fol...
What is the current status of trial NCT02255552?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2014-11-17. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT02255552?
The interventions under investigation include: eteplirsen (DRUG).
Who is sponsoring clinical trial NCT02255552?
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 NCT02255552's enrollment target sits among peer trials
109 1664th of 2000 higher than 337 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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