NCT02367014View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Mitochondrial Myopathy
Interventions
DRUG

elamipretide (low dose)

elamipretide (0.01 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days

DRUG

elamipretide (intermediate dose)

elamipretide (0.10 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days

DRUG

elamipretide (high dose)

elamipretide (0.25 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days

DRUG

Placebo

placebo (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days

Trial Locations (4)

15213

Children's Hospital of Pittsburg of UPMC, Pittsburgh

44308

Akron Children's Hospital, Akron

92093

University of California, San Diego

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Stealth BioTherapeutics Inc.

INDUSTRY

NCT02367014 - Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy | Biotech Hunter | Biotech Hunter