A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly (MOTION)
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|ClinicalTrials.gov Identifier: NCT02245620|
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skeletal Muscle Mitochondrial Dysfunction in the Elderly||Drug: Elamipretide Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of a Single Intravenous Dose of MTP-131 (Bendavia™) on Skeletal Muscle Function in the Elderly|
|Actual Study Start Date :||January 15, 2015|
|Actual Primary Completion Date :||July 6, 2016|
|Actual Study Completion Date :||July 6, 2016|
Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours.
Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours
Placebo Comparator: Placebo
Placebo (lyophilized excipients without elamipretide) given as an intravenous infusion at a rate of 60 mL/hr for 2 hours.
Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
Other Name: elamipretide
- Change From Baseline in ATPmax (Maximal ATP Synthetic Rate) [ Time Frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7 ]Maximal ATP synthetic rate (phosphorylation capacity per unit muscle volume) as determined by a muscle fatigue test.
- Mean Change From Baseline in Phosphate/Oxygen (P/O) Ratio [ Time Frame: From Baseline, Day 1 Hour 2 (2 hours after the start of infusion, or end of infusion) and Day 7 ]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.
- 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) [ Time Frame: From Baseline to Day 1 Hour 2, Day 3, and Day 7 ]Muscle Force-Time-Integral was measured as mean change from baseline at Day 1 Hour 2, Day 3, and Day 7.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245620
|United States, Washington|
|The University of Washington Medical Center|
|Seattle, Washington, United States, 98104|
|Study Director:||Jim Carr||Stealth BioTherapeutics|