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

You may not qualify if:

• Subject has myopathic signs and or/symptoms due to a neuropathic process or gait problem that would interfere with the 6 minute walk test (6MWT), in the opinion of the Investigator
• Female who are pregnant, planning to become pregnant, or breastfeeding/lactating
• At Screening, the estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
• Subject has undergone an in-patient hospitalization within the 30 days prior to the Baseline Visit or has a planned hospitalization or a surgical procedure during the trial.
• Subject has clinically significant cardiac disease or prior interventional procedure and/or respiratory disease (medical history or current clinical findings) within 3 months of the Baseline Visit, in the opinion of the Investigator.
• Subject has QTc elongation (using the correction factor utilized at the clinical site) defined as a QTc \>450 msec in male subjects and \>480 msec in female subjects.
• ECG evidence of acute ischemia, atrial fibrillation, or active conduction system abnormalities with the exception of any of the following:
• First degree Atrioventricular bock (AV-block)
• Second degree AV-block Type 1 (Mobitz Type 1 / Wenckebach type)
• Right bundle branch block
• Subject has severe vision impairment that, in the opinion of the Investigator, may interfere with their ability to complete all trial requirements
• Subject has a seizure disorder that, in the opinion of the Investigator, may interfere with their ability to complete all trial requirements.
• Active malignancy or any other cancer from which the subject has been disease-free for \< 2 years.
• Subject has a solid organ transplant and/or is currently receiving treatment with therapy for immunosuppression, in the opinion of the Investigator.
• Subject has been previously diagnosed with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• +11 more criteria