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NCT03323749 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
A Phase 3 study, sponsored by Stealth BioTherapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
NCT03323749 is a Phase 3 study that was terminated before completion, run by Stealth BioTherapeutics. The registered enrollment target is 218 participants.
The verdict
NCT03323749, a Phase 3 study, was terminated before completion, sponsored by Stealth BioTherapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
Study Summary
This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial myopathy. This will be followed by an open-label treatment extension.
Interventions
- COMBINATION_PRODUCT elamipretide
- COMBINATION_PRODUCT placebo comparator
- COMBINATION_PRODUCT elamipretide open label treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2020-02-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03323749
The ClinicalTrials.gov registry entry for NCT03323749 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which elamipretide is the first listed.
NCT03323749 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03323749 about?
NCT03323749 is a clinical study titled "A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension". This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial myopathy. This will be followed by an open-label treatment extension.
What is the current status of trial NCT03323749?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2017-10-09. Estimated completion is 2020-02-10.
What interventions are being tested in trial NCT03323749?
The interventions under investigation include: elamipretide (COMBINATION_PRODUCT), placebo comparator (COMBINATION_PRODUCT), elamipretide open label treatment (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03323749?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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