A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension — MMPOWER-3  

Primary Mitochondrial Myopathy Clinical Trial

Official title: A Phase 3 Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects With Primary Mitochondrial Myopathy Followed by an Open-Label Treatment Extension

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Part 11 is a 24-week, randomized, double-blind, parallel-group, placebo-controlled assessment of the efficacy and safety of single daily subcutaneous (SC) doses of 40 mg elamipretide (vs placebo) administered with the elamipretide delivery system as a treatment for subjects with primary mitochondrial myopathy (PMM). Part 2 was to assess the long-term safety and tolerability of single daily SC doses of 40 mg elamipretide administered with the elamipretide delivery system for up to 144 weeks. ;

Related Conditions & MeSH terms

• Mitochondrial Myopathies
• Muscular Diseases
• Primary Mitochondrial Myopathy

• NCT number: NCT03323749
• Study type: Interventional
• Source: Stealth BioTherapeutics Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: October 9, 2017
• Completion date: February 10, 2020