A Phase 1/2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Clinical Study Investigating the Safety, Tolerability, and Efficacy of Intravenous MTP-131 for the Treatment of Mitochondrial Myopathy in Subjects With Genetically Confirmed Mitochondrial Disease

Trial Profile

A Phase 1/2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Clinical Study Investigating the Safety, Tolerability, and Efficacy of Intravenous MTP-131 for the Treatment of Mitochondrial Myopathy in Subjects With Genetically Confirmed Mitochondrial Disease

Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Sep 2016

At a glance

  • Drugs Elamipretide (Primary)
  • Indications Mitochondrial myopathies
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms MMPOWER
  • Sponsors Stealth BioTherapeutics
  • Most Recent Events

    • 12 Sep 2016 According to Stealth BioTherapeutics media release, the company hopes to use results of this study and MMPOWER 2 study to engage in discussions with regulators to develop the design for a Phase 3 trial in primary mitochondrial disease
    • 17 Jun 2016 Primary endpoint has been met. (Change in distance walked (meters) on the 6-minute walk test (6MWT) for higher dose (0.25 mg/kg/hr)), as per Stealth BioTherapeutics media release.
    • 17 Jun 2016 Results also presented at Mitochondrial Medicine 2016, the United Mitochondrial Disease Foundation (UMDF) symposium, as per Stealth BioTherapeutics media release.
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