CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Elamipretide +1 moredrug
Likely dose
40 mg elamipretide administered once daily subcutaneouslyAI-extracted
Key inclusion· 4
  • ✓Completed SPIMM-201 study participation without significant protocol deviation
  • ✓Reside in North America for study duration
  • ✓No study drug received in SPIMM-201 within 3 weeks prior to screening
  • ✓Stable medications for at least 1 month prior to baseline
Key exclusion· 8
  • ✕Medical condition preventing safe study completion (e.g., unstable angina, recent MI)
  • ✕Participation in another interventional clinical study within 30 days prior to baseline
  • ✕Adverse reaction to study drug in SPIMM-201 contraindicating further elamipretide treatment
  • ✕Inpatient hospitalization within 1 month prior to screening or anticipated during study

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

Search/NCT02805790
NCT02805790Phase 2Completed
CompareCT.gov

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate Safety, Tolerability, and Efficacy of Subcutaneous Injections of MTP-131 in Subjects With Mitochondrial Myopathy Previously Treated in the SPIMM-201 Study

Stealth BioTherapeutics Inc.·interventional·Posted Jun 20, 2016·Updated Jul 17, 2020

In Brief

A Phase 2 clinical trial evaluating Elamipretide and Placebo for Primary Mitochondrial Disease. Completed, enrolled 30 participants across 4 sites.

Detailed Summary

This randomized, double-blind, placebo-controlled, crossover study screened 32 subjects with primary mitochondrial myopathy (PMM) to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of subcutaneous elamipretide in this patient population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Mitochondrial Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 20, 2016
Enrollment StartAug 22, 2016
Primary CompletionMar 10, 2017
Study CompletionMar 23, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.0 years ago

Interventions

Elamipretidedrug

4 weeks of treatment with 40 mg elamipretide administered once daily subcutaneously

Placebodrug

4 weeks of treatment with placebo administered once daily subcutaneously