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NCT01396239 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients
A Phase 2 study, sponsored by Sarepta Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01396239 is a Phase 2 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT01396239, a Phase 2 study, has completed, sponsored by Sarepta Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).
Interventions
- OTHER Placebo
- DRUG AVI-4658 (Eteplirsen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01396239
The ClinicalTrials.gov registry entry for NCT01396239 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 2 interventions - of which Placebo is the first listed.
NCT01396239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01396239 about?
NCT01396239 is a clinical study titled "Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients". This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).
What is the current status of trial NCT01396239?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-07. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01396239?
The interventions under investigation include: Placebo (OTHER), AVI-4658 (Eteplirsen) (DRUG).
Who is sponsoring clinical trial NCT01396239?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
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