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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03862846
Other study ID # REN001-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date May 10, 2019
Est. completion date April 23, 2020

Study information

Verified date March 2020
Source Reneo Pharma Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date April 23, 2020
Est. primary completion date April 23, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Intervention

Drug:
REN001
Once daily

Locations

Country Name City State
United Kingdom Institute of Neurology, University College London London
United Kingdom Wellcome Centre for Mitochondrial Research Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor Collaborator
Reneo Pharma Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Number of participants with Adverse Events as a measure of safety and tolerability Comparing Baseline to Week 12
Secondary Adverse Events Number of participants with Adverse Events as a measure of safety and tolerability Continous to Week 48
See also
  Status Clinical Trial Phase
Terminated NCT03323749 - A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension Phase 3
Completed NCT04535609 - An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients Phase 2
Terminated NCT04641962 - A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy Phase 2
Terminated NCT05267574 - An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead) Phase 2/Phase 3