Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

Primary Mitochondrial Disease Clinical Trial

Official title: A Multicenter, Open-Label Phase 2 Extension Trial to Characterize the Long-term Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

Status Terminated

Clinical Trial Summary

This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial

Clinical Trial Description

This open-label, non-comparative, extension trial will enroll subjects with genetically confirmed PMD who have completed the End-of-Study Visit in the SPIMM-202 trial. Subjects who do not discontinue or withdraw from the trial will receive treatment with 40 mg SC elamipretide for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD. ;

Related Conditions & MeSH terms

• Mitochondrial Diseases
• Mitochondrial Myopathies
• Primary Mitochondrial Disease

• NCT number: NCT02976038
• Study type: Interventional
• Source: Stealth BioTherapeutics Inc.
• Status: Terminated
• Phase: Phase 2
• Start date: December 2016
• Completion date: April 9, 2020