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NCT02310906 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of SRP-4053 in DMD Patients
A Phase 1 study, sponsored by Sarepta Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02310906: Completed Phase 1 study, sponsored by Sarepta Therapeutics.
NCT02310906 is a Phase 1 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02310906, a Phase 1 study, has completed, sponsored by Sarepta Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.
Primary Outcome
Adverse event (AE) was any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with the investigational drug. A Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; Life-threatening event; Required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs that were reported or worsened on or after the start of study drug d
Interventions
- DRUG Placebo
- DRUG SRP-4053
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-01-13 |
| Est. Completion | 2019-03-25 |
| Phase | Phase 1 |
What the finished NCT02310906 record still lists
NCT02310906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02310906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02310906 about?
NCT02310906 is a clinical study titled "Phase I/II Study of SRP-4053 in DMD Patients". This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.
What is the current status of trial NCT02310906?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2015-01-13. Estimated completion is 2019-03-25.
What interventions are being tested in trial NCT02310906?
The interventions under investigation include: Placebo (DRUG), SRP-4053 (DRUG).
Who is sponsoring clinical trial NCT02310906?
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 NCT02310906's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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