CREST-E Phase III trial of high dose creatine for participants with motor diagnosis of HD.

Trial status: Actively enrolling at multiple sites in North America.

FDA phase: Phase III

Sponsor: National Institutes of Health and Massachusetts General Hospital.

Trial Design: Randomized, double blind, placebo controlled trial of 30 grams of creatine per day compared to placebo. It will enroll up to 650 participants from over 40 HSG centers for a three year time period.

Outcome measures include total functional capacity (TFC), UHDRS, quality of life measures, changes in oxidative markers in blood, and morphmetric MRI at yearly intervals. Morphometric MRI measures whole brain volume.

Drug is being supplied by Avicena Group, Inc.

Trial Locations may be found on the ClinicaTrials.gov site