CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Elamipretide +1 moredrug
Likely dose
Elamipretide 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02245620
NCT02245620Phase 2Completed

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

Stealth BioTherapeutics Inc.·interventional·Posted Sep 19, 2014·Updated Jun 23, 2020

In Brief

A Phase 2 clinical trial evaluating Elamipretide and Placebo for Skeletal Muscle Mitochondrial Dysfunction in the Elderly. Completed, enrolled 41 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 19, 2014
Enrollment StartJan 15, 2015
Primary CompletionJul 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.8 years ago

Interventions

Elamipretidedrug

Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours

Placebodrug

Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours