A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly

What Was Tested

This registered phase 2 trial tested SS-31 (Elamipretide) for 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.

It had two arms (groups): Elamipretide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Each treatment group went through three distinct periods: Screening (up to 28 days), Treatment (1day), and Observation (7 days).

Who Took Part

The registry lists 41 actual participants took part.

It was open to people of any sex aged from 60 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got SS-31 (Elamipretide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the mitochondrial dysfunction participants stayed in one arm throughout.

Blinding on both sides kept the mitochondrial dysfunction participants and researchers unaware of who received SS-31 (Elamipretide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-01-15 with completion listed for 2016-07-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 3 secondary outcomes, for example Mean Change From Baseline in Phosphate/Oxygen (P/O) Ratio, Mean Change From Baseline in Nicotine Adenine Dinucleotide (NAD) and Mean Change From Baseline in Muscle Force-Time-Integral (FTI).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of SS-31 (Elamipretide) in 41 people with mitochondrial dysfunction.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the SS-31 (Elamipretide) compound page, Mitochondrial dysfunction research.