Trials / Completed
CompletedNCT04535609
An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients
A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With REN001 in Patients With Primary Mitochondrial Myopathy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Reneo Pharma Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mavodelpar | Once daily |
| DRUG | Placebo | Once daily |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2023-09-12
- Completion
- 2023-10-05
- First posted
- 2020-09-02
- Last updated
- 2024-05-08
- Results posted
- 2024-04-03
Locations
41 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, New Zealand, Norway, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04535609. Inclusion in this directory is not an endorsement.