Mitochondrial Myopathy Treatment With RTA 408: The MOTOR Study – Phase II

Study of RTA 408 in the Treatment of Mitochondrial Myopathy (MOTOR)

Protocol Description

The purpose of this multi-center study is to evaluate the effects of RTA 408 (omaveloxolone), taken in pill form, for treatment of mitochondrial myopathy. Mitochondrial diseases are rare and occur when one or more genetic mutations result in mitochondria failing to create enough energy to support the body. Mitochondrial myopathy is a consequence of those mitochondrial diseases that cause muscular problems.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study accepts male and female patients, ages 18 to 75, who have a genetically confirmed mitochondrial myopathy. Genetic testing can be performed as part of the screening visit, if not already completed.
Males and Females: Ages 18 to 75

Requirements

Following an initial screening visit, which will include a physical exam and various physical tests, participants enrolled in the study will be randomly chosen to receive either the study drug or a placebo to be taken for 12 weeks. Study drug dosage levels for participant groups are pre-determined by study parameters. Over the course of their enrollment, participants will have a total of 12 visits, most of which will include physical exams and blood and urine tests. Two visits will be conducted via telephone to discuss health, and questions about side effects and the medication.
Visits: 12
Duration: about 20 weeks

Status: Enrolling by Invitation

Source(s) of Support

Reata Pharmaceuticals

Primary Investigator

Gerard Vockley, MD, PhD

Contact Information

For more information about the study or enrollment, please contact:
Michele Graham, RN
412-692-3476