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NCT02367014 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
A Phase 1 study of Mitochondrial Myopathy, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT02367014: Completed Phase 1 study of Mitochondrial Myopathy, sponsored by Stealth BioTherapeutics.
NCT02367014 is a Phase 1 study of Mitochondrial Myopathy that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02367014, a Phase 1 study of Mitochondrial Myopathy, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
Study Summary
Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient population.
Primary Outcome
Change in distance walked as measured by meters on the 6-minute walk test from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG elamipretide (low dose)
- DRUG elamipretide (intermediate dose)
- DRUG elamipretide (high dose)
Study Locations (4)
California
- University of California - San Diego
Massachusetts
- Massachusetts General Hospital - Boston
Ohio
- Akron Children's Hospital - Akron
Pennsylvania
- Children's Hospital of Pittsburg of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT02367014 record still lists
NCT02367014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Mitochondrial Myopathy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02367014 reports a single indexed study location in California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT02367014 about?
NCT02367014 is a clinical study titled "Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy". Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy...
What is the current status of trial NCT02367014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-02. Estimated completion is 2016-04.
What conditions does trial NCT02367014 study?
This clinical trial studies the following conditions: Mitochondrial Myopathy.
What interventions are being tested in trial NCT02367014?
The interventions under investigation include: Placebo (DRUG), elamipretide (low dose) (DRUG), elamipretide (intermediate dose) (DRUG), elamipretide (high dose) (DRUG).
Who is sponsoring clinical trial NCT02367014?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02367014 being conducted?
This trial has 4 study locations across California, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02367014's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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