This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether the administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics or muscle performance in age-related skeletal muscle mitochondrial dysfunction.
This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether the administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics or muscle performance in age-related skeletal muscle mitochondrial dysfunction. Subjects were randomized 1:1 to receive either elamipretide at 0.25 mg/kg/hr intravenously at a rate of 60 mL/hr for 2 hours, or placebo (lyophilized excipients without elamipretide) intravenously at a rate of 60 mL/hr for 2 hours. Each treatment group went through three distinct periods: Screening (up to 28 days), Treatment (1day), and Observation (7 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours
Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
The University of Washington Medical Center
Seattle, Washington, United States
Change From Baseline in ATPmax (Maximal ATP Synthetic Rate)
Maximal ATP synthetic rate (phosphorylation capacity per unit muscle volume) as determined by a muscle fatigue test.
Time frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
Mean Change From Baseline in Phosphate/Oxygen (P/O) Ratio
As a measure of mitochondrial hand skeletal muscle energetics, mitochondrial coupling, or Phosphate/Oxygen ratio (P/O) was assessed at Baseline, Day 1 Hour 2, and Day 7.
Time frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
Mean Change From Baseline in Nicotine Adenine Dinucleotide (NAD)
Time frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7
Mean Change From Baseline in Muscle Force-Time-Integral (FTI)
Muscle Force-Time-Integral was measured as mean change from baseline at Day 1 Hour 2, Day 3, and Day 7.
Time frame: From Baseline to Day 1 Hour 2, Day 3, and Day 7
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