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NCT03769116 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-blind, Placebo-controlled Study of Delandistrogene Moxeparvovec (SRP-9001) for Duchenne Muscular Dystrophy (DMD)
A Phase 1 study, sponsored by Sarepta Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT03769116 is a Phase 1 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 41 participants.
The verdict
NCT03769116, a Phase 1 study, has completed, sponsored by Sarepta Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer in DMD participants by measuring biological and clinical endpoints in three parts: two 48-week randomized, double-blinded, placebo-controlled periods (Part 1 and Part 2), and an open-label follow-up period (Part 3). Participants who are randomized to placebo in Part 1 will have the opportunity for treatment with delandistrogene moxeparvovec in Part 2. In order to provide a uniform approach to monitoring long-term safety and efficacy in participants who received SRP-9001 in a clinical trial, the Sponsor has amended Study Completion for this study to occur at Week 130. Therefore, participants have transitioned and will complete the remainder of the Part 3 follow up visits in a long-term extension study, SRP-9001-305 (NCT05967351).
Interventions
- GENETIC delandistrogene moxeparvovec
- GENETIC placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-12-05 |
| Est. Completion | 2023-08-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03769116
The ClinicalTrials.gov registry entry for NCT03769116 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 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 delandistrogene moxeparvovec is the first listed.
NCT03769116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03769116 about?
NCT03769116 is a clinical study titled "A Randomized, Double-blind, Placebo-controlled Study of Delandistrogene Moxeparvovec (SRP-9001) for Duchenne Muscular Dystrophy (DMD)". The purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer in DMD participants by measuring biological and clinical endpoints in three parts: two 48-week randomized, double-blinded, placebo-controlled periods (Part 1 and Part 2), and an open-label follow-up period (P...
What is the current status of trial NCT03769116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-12-05. Estimated completion is 2023-08-16.
What interventions are being tested in trial NCT03769116?
The interventions under investigation include: delandistrogene moxeparvovec (GENETIC), placebo (GENETIC).
Who is sponsoring clinical trial NCT03769116?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
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