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NCT03098797 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
A Phase 2 study of Barth Syndrome, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03098797: Completed Phase 2 study of Barth Syndrome, sponsored by Stealth BioTherapeutics.
NCT03098797 is a Phase 2 study of Barth Syndrome that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03098797, a Phase 2 study of Barth Syndrome, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.
Primary Outcome
Average distance walked in meters during the 6-minute walk test (6MWT) at end of treatment, where end of treatment means end of Visit 5 (Week 12) for Period 1 and end of Visit 10 (Week 12) for Period 2. Results were pooled for each 12 week period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Elamipretide
Study Locations (1)
Maryland
- McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2021-10-11 |
| Phase | Phase 2 |
What the finished NCT03098797 record still lists
NCT03098797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Barth Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03098797 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03098797 about?
NCT03098797 is a clinical study titled "A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome". A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.
What is the current status of trial NCT03098797?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2017-07-05. Estimated completion is 2021-10-11.
What conditions does trial NCT03098797 study?
This clinical trial studies the following conditions: Barth Syndrome.
What interventions are being tested in trial NCT03098797?
The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG).
Who is sponsoring clinical trial NCT03098797?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03098797 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Barth Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03098797's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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