Announcement of CREST-E Early Study Closure
The National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health (NIH), has discontinued its study of creatine for treating the progressive functional decline that occurs in Huntington’s Disease (HD). The study, known as the Creatine Safety, Tolerability and Efficacy study (CREST-E), was being conducted by the Huntington Study Group (HSG) under the leadership of Dr. Steven Hersch of Massachusetts General Hospital and Dr. Giovanni Schifitto of the University of Rochester School of Medicine.. The CREST-E Data and Safety Monitoring Board (DSMB) recently reviewed the existing study data from a planned interim analysis. The DSMB reported that there were no safety concerns. However the analysis also showed with high confidence that it was unlikely that the study would be able to show that creatine was effective in slowing loss of function in early symptomatic Huntington’s Disease. Site investigators and coordinators have informed participants of the study closure and have encouraged each participant to schedule a final visit to their research center.
The CREST-E study enrolled 551 research participants with early Huntington’s Disease from 46 sites throughout the United States, Canada, Australia, and New Zealand. Participants were randomized to receive up to 40 grams per day of active creatine or matching placebo for a treatment period up to four years in duration. The Principal Investigators and the Huntington Study Group are committed to conducting a detailed analysis of the complete data set from the CREST-E study and to disseminating the results through the scientific review process. Even though creatine was not found to slow the progression of HD, the study amassed a large amount of invaluable longitudinal clinical and biological data, which will provide considerable information to facilitate future clinical studies. It has also produced a unique safety database for creatine and has demonstrated the feasibility of conducting such a large controlled clinical trial in Huntington’s Disease. The research team is indebted to the participants for their time and dedication to this study.
Any questions or comments may be directed to the Huntington Study Group – 800-487-7671 (Toll Free – North America).