Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 12 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01540409
The ClinicalTrials.gov registry entry for NCT01540409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarepta Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AVI-4658 (Eteplirsen) is the first listed.
NCT01540409 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.