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NCT04004065 · ClinicalTrials.gov registry record · Phase 2
Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Expansion (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment
A Phase 2 study, sponsored by Sarepta Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT04004065 is a Phase 2 study that was terminated before completion, run by Sarepta Therapeutics. The registered enrollment target is 62 participants.
The verdict
NCT04004065, a Phase 2 study, was terminated before completion, sponsored by Sarepta Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will be comprised of 2 parts: 1) Part A (Multiple Ascending Dose \[MAD\]) will be conducted to evaluate the safety and tolerability of vesleteplirsen at MAD levels to determine the maximum tolerated dose (MTD), and 2) Part B will be conducted to further evaluate the vesleteplirsen doses selected in Part A. Participants enrolling in Part B will be those who completed Part A or Study 5051-102 (NCT03675126) and meet applicable eligibility criteria for Part B, as well as additional participants who meet applicable eligibility criteria for enrollment at the beginning of Part B.
Interventions
- DRUG Vesleteplirsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2025-02-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04004065
The ClinicalTrials.gov registry entry for NCT04004065 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 62 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 Vesleteplirsen is the first listed.
NCT04004065 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04004065 about?
NCT04004065 is a clinical study titled "Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Expansion (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment". This study will be comprised of 2 parts: 1) Part A (Multiple Ascending Dose \[MAD\]) will be conducted to evaluate the safety and tolerability of vesleteplirsen at MAD levels to determine the maximum tolerated dose (MTD), and 2) Part B will be conducted to further evaluate the vesleteplirsen doses s...
What is the current status of trial NCT04004065?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2019-06-26. Estimated completion is 2025-02-07.
What interventions are being tested in trial NCT04004065?
The interventions under investigation include: Vesleteplirsen (DRUG).
Who is sponsoring clinical trial NCT04004065?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
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