Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

Exclusion Criteria

• •Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements.
• •Had any exclusionary Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores at Screening Visit.
• •Hospitalized (admitted as in-patient) within 1 month prior to the Baseline Visit.
• •A history of type 1 diabetes mellitus (T1DM).
• •Uncontrolled Type 1 (T1DM) or Type 2 diabetes mellitus (T2DM), in the opinion of the investigator.
• •A creatinine clearance \<45 mL/min as calculated by the Cockcroft Gault equation.
• •Requires pacemaker, defibrillator, or has undergone cardiac surgery within 2 years of Screening Visit.
• •QTc elongation defined as a QTc \>450 msec in male subjects and \>480 msec in female subjects.
• •Uncontrolled hypertension (\>160 mmHg systolic or \>100 mmHg diastolic) at Screening Visit.
• •History of rhabdomyolysis defined as an acute rise in the serum creatine phosphokinase (CPK) value that, in the opinion of the investigator, caused clinically significant symptoms.
• •Serum sodium more than 5 meq/L below the reference lower limit of normal at Screening Visit.
• •Participated in another interventional clinical trial within 3 months of the screening visit or is currently enrolled in a non-interventional clinical trial judged by the Investigator to be incompatible with the current trial.