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NCT05162768 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
A Phase 3 study, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT05162768 is a Phase 3 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 102 participants.
The verdict
NCT05162768, a Phase 3 study, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).
Interventions
- DRUG Placebo
- DRUG Elamipretide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-04-29 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05162768
The ClinicalTrials.gov registry entry for NCT05162768 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 102 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 2 interventions - of which Placebo is the first listed.
NCT05162768 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05162768 about?
NCT05162768 is a clinical study titled "Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)". SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).
What is the current status of trial NCT05162768?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2022-04-29. Estimated completion is 2024-12-04.
What interventions are being tested in trial NCT05162768?
The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG).
Who is sponsoring clinical trial NCT05162768?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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