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NCT05881408 · ClinicalTrials.gov registry record · Phase 3
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
A Phase 3 study of Duchenne Muscular Dystrophy, sponsored by Sarepta Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
- 20
- Study locations
NCT05881408 is a Phase 3 study of Duchenne Muscular Dystrophy that is active but no longer recruiting, run by Sarepta Therapeutics. The registered enrollment target is 148 participants, below the 409-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 18 states.
The verdict
NCT05881408, a Phase 3 study of Duchenne Muscular Dystrophy, is active but no longer recruiting, sponsored by Sarepta Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants will have the opportunity to receive intravenous (IV) delandistrogene moxeparvovec in either Part 1 or Part 2.
Conditions Studied
Interventions
- GENETIC delandistrogene moxeparvovec
- GENETIC placebo
Study Locations (20)
California
- Lucile Packard Children's Hospital Stanford - Palo Alto
- University of California at Davis Medical Center - Sacramento
- Rady Children's Hospital-San Diego - San Diego
Arkansas
- Arkansas Children's Hospital - Little Rock
Florida
- University of Florida, UF Health Center for Pediatric Neuromuscular and Rare Diseases - Gainesville
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Maryland
- The Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center, Pediatric Clinical Research Unit - Baltimore
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- Washington University of St. Louis, St. Louis Children's Hospital - St Louis
New York
- University of Rochester, Department of Neurology - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05881408
The ClinicalTrials.gov registry entry for NCT05881408 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 409-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (64% lower). The listed sponsor is Sarepta Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which delandistrogene moxeparvovec is the first listed.
NCT05881408 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT05881408 about?
NCT05881408 is a clinical study titled "A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)". The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants ...
What is the current status of trial NCT05881408?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2023-05-31. Estimated completion is 2028-06-30.
What conditions does trial NCT05881408 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT05881408?
The interventions under investigation include: delandistrogene moxeparvovec (GENETIC), placebo (GENETIC).
Who is sponsoring clinical trial NCT05881408?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05881408 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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