A Study of Resveratrol as Treatment for Friedreich Ataxia

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of two doses of resveratrol taken for a 12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will also measure the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia, and cardiac parameters.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborator: Friedreich's Ataxia Research Alliance
• Treatments: Resveratrol

Criteria

Inclusion Criteria:

• Adults with Friedreich ataxia due to homozygosity for the GAA repeat expansion in intron 1 of the FXN gene

• Functional stage on the Ataxia subscale of the FARS of 1 or higher

Exclusion Criteria:

• Women who are pregnant or lactating

• Active arrythmias or significant cardiac insufficiency

• Use of idebenone, Coenzyme Q or vitamin E within 30 days prior to enrolment

• Use of amiodarone or other medications which may have clinically significant drug interactions that cannot be safely monitored