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NCT03675126 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)
A Phase 1 study, sponsored by Sarepta Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03675126: Clinical Trial Phase 1 study, sponsored by Sarepta Therapeutics.
NCT03675126 is a Phase 1 study that was terminated before completion, run by Sarepta Therapeutics. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03675126, a Phase 1 study, was terminated before completion, sponsored by Sarepta Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this extension study is to evaluate the safety, tolerability, and pharmacokinetics of repeat administrations of SRP-5051 (vesleteplirsen) in participants with Duchenne muscular dystrophy (DMD) who participated in studies of SRP-5051.
Primary Outcome
A TEAE was any untoward medical occurrence in a clinical study participant that did not necessarily have a causal relationship with the study drug. A TEAE could, therefore, be any unfavorable and unintended symptom, sign, disease, condition, or test abnormality that occurred during or after administration of the study drug, whether or not considered related to the study drug. A summary of serious and all other non-serious TEAEs regardless of causality is located in the Reported Adverse Events mo
Interventions
- DRUG SRP-5051
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2021-08-25 |
| Phase | Phase 1 |
Why NCT03675126 stopped before completion
NCT03675126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which SRP-5051 is the first listed.
NCT03675126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03675126 about?
NCT03675126 is a clinical study titled "An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)". The purpose of this extension study is to evaluate the safety, tolerability, and pharmacokinetics of repeat administrations of SRP-5051 (vesleteplirsen) in participants with Duchenne muscular dystrophy (DMD) who participated in studies of SRP-5051.
What is the current status of trial NCT03675126?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-12-19. Estimated completion is 2021-08-25.
What interventions are being tested in trial NCT03675126?
The interventions under investigation include: SRP-5051 (DRUG).
Who is sponsoring clinical trial NCT03675126?
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 NCT03675126's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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