The Phase III clinical trial for creatine is still enrolling. We have updated information about the trial below.
The Huntington Study Group (HSG) and Massachusetts General Hospital (Steven M. Hersch, MD, PhD) are conducting a Phase 3 randomized, double-blind, placebo-controlled clinical trial in Huntington's Disease (HD). The CREST-E study is designed to assess the effects of high-dose creatine to slow the progression of functional decline that occurs in HD, to examine the long-term safety and tolerability of creatine, and to assess potential changes in the body and brain due to creatine.
Creatine has been shown to reduce brain shrinkage and to extend survival in transgenic mouse models of HD and to reduce oxidative stress markers in blood and brain. In a preliminary clinical study in individuals with HD, creatine has been shown to be safe, tolerable, bioavailable in brain, and to reduce serum 8OH2'dG (an indicator of oxidative injury to DNA).
Unlike what is available for purchase over the counter as a nutritional supplement, the creatine in CREST-E is pharmaceutical grade. The high-doses being studied in this study have not been used before and so monitoring its safety at study visits is an important aspect of the study, even though many people take creatine at lower doses.
The CREST-E study is actively enrolling!
Approximately 60 clinical sites globally will enroll up to 650 research participants for 3 years of follow-up.
This study is sponsored by the National Institutes of Health/National Center for Complementary and Alternative Medicine (NIH/NCCAM).
For more information call the Huntington Study Group 800-487-7671 or visit www.huntington-study-group.org.
To find a study center near you, visit www.clinicaltrials.gov/ (NCT00712426)
Name: CREST-E HD Study
Trial Status: Actively Enrolling
Countries: North America, Australia, New Zealand
Phase: Phase III
Sponsors: National Institutes of Health/NCCAM
Study Drug: Creatine Monohydrate is considered a nutritional supplement. Preliminary evidence shows extended survival in HD transgenic mouse models and reduction of oxidative markers in blood and brain with creatine. Unlike what is available for purchase over the counter as a nutritional supplement, the creatine in CREST-E is pharmaceutical grade. The high-doses being studied in this study have not been used before and are considered investigational. Monitoring its safety is an important aspect of the study, even though many people take creatine at lower doses.
• 18 years or older
• Early (Mild to Moderate) HD
• Not on investigational product
• Additional inclusion/exclusion criteria apply
Trial Design: Randomized, double blind, placebo controlled trial of high-dose creatine in early symptomatic Huntington's disease. Approximately 60 clinical sites globally will enroll up to 650 research participants for 3 years of follow-up.
Outcome Measures: Functional decline in HD, long-term safety and tolerability of creatine, oxidative markers in blood, and other potential changes in the body and brain.
Assessments: UHDRS, quality of life measures, lab evaluations, EKG, changes in body and brain markers.