Status:
TERMINATED
A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy
Lead Sponsor:
Reneo Pharma Ltd
Conditions:
Primary Mitochondrial Myopathy
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess REN001 safety in subjects with primary mitochondrial myopathy
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03862846
Start Date
May 10 2019
End Date
April 23 2020
Last Update
July 16 2020
Active Locations (2)
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1
Institute of Neurology, University College London
London, United Kingdom, WC1N 3BG
2
Wellcome Centre for Mitochondrial Research
Newcastle upon Tyne, United Kingdom, NE2 4HH