MedTrace Logo

An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)

NCT05267574 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2024-05-28

Study results available
· View outcomes & findings →

Summary

This study is designed to evaluate the long-term safety and tolerability of REN001 administered once daily to subjects with PMM due to mitochondrial DNA mutations (mtDNA-PMM) or nuclear DNA mutations (nDNA-PMM). Subjects with mtDNA mutations will have previously completed Study REN001-201 or participated in Study REN001-101. Subjects with nDNA mutations who enroll in this study will be REN001- naïve.

Conditions

  • Primary Mitochondrial Myopathy

Interventions

DRUG

REN001

Once daily dosing

Sponsors & Collaborators

  • Reneo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Grainne Gorman, MD · Newcastle Hospital NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-12-14
Completion
2024-01-31
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

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 NCT05267574 on ClinicalTrials.gov