TerminatedPhase 1

A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy

Stopped: COVID-19 Pandemic sufficient data gathered to achieve the study objective

United Kingdom23 participantsStarted 2019-05-10

Plain-language summary

The purpose of this study is to assess REN001 safety in subjects with primary mitochondrial myopathy

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must give written, signed and dated informed consent * Confirmed diagnosis of PMM according to the 2016 Rome Consensus recommendations * Confirmed mitochondrial mutation with evidence of myopathy * Able to remain on stable medication throughout the study Exclusion Criteria: * Documented evidence of ongoing rhabdomyolysis * Subjects with motor abnormalities other than related to mitochondrial disease * Treatment with an investigational drug within 3 months prior to Day 1 * Hospitalised within 3 months prior to screening for any major medical condition * Pregnant or nursing females

What they're measuring

Adverse Events

Timeframe: Comparing Baseline to Week 12

Trial details

NCT IDNCT03862846

SponsorReneo Pharma Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-23

View on ClinicalTrials.gov More Primary Mitochondrial Myopathy trials