TerminatedPhase 3

A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

Stopped: Part1,double blind portion of the trial did not meet the primary end points

United States218 participantsStarted 2017-10-09

Plain-language 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.

Who can participate

Age range16 Years – 80 Years

SexALL

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Exclusion criteria

✕. First degree Atrioventricular bock (AV-block)
✕. Second degree AV-block Type 1 (Mobitz Type 1 / Wenckebach type)
✕. Right bundle branch block

What they're measuring

Six-minute Walk Test (6MWT)

Timeframe: Baseline to 24 weeks

Total Fatigue Score on the on the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA)

Timeframe: Baseline to 24 weeks

Trial details

NCT IDNCT03323749

SponsorStealth BioTherapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-10

Results submitted2021-02-08

View on ClinicalTrials.gov More Primary Mitochondrial Myopathy trials