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

NCT03323749 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2022-01-24

Study results available
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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.

Conditions

  • Primary Mitochondrial Myopathy

Interventions

COMBINATION_PRODUCT

elamipretide

40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system

COMBINATION_PRODUCT

placebo comparator

40 mg of placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system

COMBINATION_PRODUCT

elamipretide open label treatment

40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2020-02-10
Completion
2020-02-10
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Hungary
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323749 on ClinicalTrials.gov