MOXIe
Research type
Research Study
Full title
A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich’s Ataxia
IRAS ID
187031
Contact name
Paola Giunti
Contact email
Sponsor organisation
Reata Pharmaceuticals, Inc.
Eudract number
2015-002762-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Researchers want to find out if RTA 408, a drug being developed by Reata Pharmaceuticals, can improve Friedreich’s ataxia.
RTA 408 is an investigational (experimental) drug that is being tested and is not currently approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency for sale in the United States or any other country. It is a semi-synthetic (man-made) substance from natural plant extract that has anti-inflammatory, antioxidant, and anticancer properties. In this study, RTA 408 will be given to participants as a capsule (pill).
This research study has 3 purposes:
- To see if the RTA 408 pills are safe and well tolerated in patients with Friedreich’s ataxia
- To see if the RTA 408 pills affect patients’ exercise ability and Friedreich’s ataxia disease symptoms
- To test how the RTA 408 pills affect patients’ blood cells and muscle cells.
The study plans to enroll up to 100 patients with Friedreich’s ataxia from up to 12 study centers who are between the ages of 16 and 40.REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0666
Date of REC Opinion
14 Dec 2015
REC opinion
Further Information Favourable Opinion