At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 213 enrolled
Drug / intervention
Mavodelpar +1 moredrug
Likely dose
Not stated in 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 Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With REN001 in Patients With Primary Mitochondrial Myopathy
In Brief
A Phase 2 clinical trial evaluating Mavodelpar and Placebo for Primary Mitochondrial Myopathy. Completed, enrolled 213 participants across 41 sites in 15 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel group, multi-centre, study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Mitochondrial Myopathy
CountriesAustralia, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, New Zealand, Norway, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartMay 2021
Primary CompletionSep 2023
Study CompletionOct 2023
TodayJul 2026
First PostedSep 2, 2020
Enrollment StartMay 21, 2021
Primary CompletionSep 12, 2023
Study CompletionOct 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.8 years ago
Interventions
Mavodelpardrug
Once daily
Placebodrug
Once daily