Change From Baseline in ATPmax (Maximal ATP Synthetic Rate)
| Group | Value (mM/sec) | Spread |
|---|---|---|
| MTP-131 (Bendavia™) | 0.17 | 0.196 |
| Placebo | 0.12 | 0.244 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name MOTION
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Elamipretide
Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr 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.
Outcomes the sponsor listed as primary.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mM/sec) | Spread |
|---|---|---|
| MTP-131 (Bendavia™) | 0.17 | 0.196 |
| Placebo | 0.12 | 0.244 |
| Group | Value (ratio of phosphate to oxygen) | Spread |
|---|---|---|
| MTP-131 (Bendavia™) | 0.25 | 0.679 |
| Placebo | 0.26 | 0.693 |
| Group | Value (millimolar) | Spread |
|---|---|---|
| MTP-131 (Bendavia™) | 0.04 | 0.169 |
| Placebo | 0.01 | 0.213 |
| Group | Value (Newton/second) | Spread |
|---|---|---|
| MTP-131 (Bendavia™) | 0.43 | 0.882 |
| Placebo | 0.10 | 0.728 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ElamipretideElamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours. Elamipretide: Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours | 0 / 19 | 0 / 19 | 3 / 19 |
| PlaceboPlacebo (lyophilized excipients without elamipretide) given as an intravenous infusion at a rate of 60 mL/hr for 2 hours. Placebo: Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours | 0 / 20 | 0 / 20 | 2 / 20 |
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