At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 enrolled
Drug / intervention
Elamipretide +1 moredrug
Likely dose
Elamipretide 40 mgfrom 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.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety and Efficacy of Subcutaneous Injections of Elamipretide in Subjects With Genetically Confirmed Barth Syndrome Followed by Open-Label Treatment
In Brief
A Phase 3 clinical trial evaluating Elamipretide and Placebo for Barth Syndrome. Completed, enrolled 12 participants across 1 site.
Detailed Summary
A randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with Barth syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarth Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJul 2017
Primary CompletionOct 2018
Study CompletionOct 2021
TodayJul 2026
First PostedApr 4, 2017
Enrollment StartJul 5, 2017
Primary CompletionOct 5, 2018
Study CompletionOct 11, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.2 years ago
Interventions
Elamipretidedrug
40 mg daily subcutaneous injection for 12 weeks
Placebodrug
daily subcutaneous injection for 12 weeks