REN001 for Adults with Primary Mitochondrial Myopathy

REN001 for Adults with Primary Mitochondrial Myopathy

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This study is no longer recruiting.

Description
The purpose of this new clinical trial is to investigate study drug “REN001” in adult patients with Primary Mitochondrial Myopathy. REN001 is currently not approved by the U.S. Food and Drug Administration nor any other regulatory agencies for this disease; it is considered an experimental drug. The study period will last for approximately 9 months and will include at least 4 outpatient visits at CHOP, where participants will be provided the study drug or placebo and monitored for safety. The study also involves blood and urine tests, cardiac tests, physical exercise tests, and other study procedures. For more information: https://www.clinicaltrials.gov/ct2/show/NCT04535609 Participants will be able to receive travel support and reimbursement for related expenses.

Eligibility and criteria
IRB Number:
21-018417
Eligible age range:
18 years - 99 years
Clinical trial phase:
Phase II
Official title:
A Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment with REN001 in Patients with Primary Mitochondrial Myopathy (PMM)

What to expect

Related specialties
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