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

• Status: Terminated
• Trial end date: 2020-04-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reneo Pharma Ltd

Criteria

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