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An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients

NCT04535609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-05-08

Study results available
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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

  • Primary Mitochondrial Myopathy

Interventions

DRUG

Mavodelpar

Once daily

DRUG

Placebo

Once daily

Sponsors & Collaborators

  • Reneo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Amel Karaa, MD · Massachusetts General Hospital (MGH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2023-09-12
Completion
2023-10-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535609 on ClinicalTrials.gov