Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.Creatine monohydrate is considered a nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow the progressive functional decline that occurs in persons 18 years or older with early clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40 grams daily creatine compared to placebo is studied. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Up to 50 active research centers globally will enroll 650 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
553
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
University of Alabama
Birmingham, Alabama, United States
University of California, Irvine
Irvine, California, United States
University of California Davis
Sacramento, California, United States
University of Connecticut
Farmington, Connecticut, United States
University of Florida (McKnight Brain Institute)
Gainesville, Florida, United States
Change in Total Functional Capacity
Study duration depends on each subject's calendar date of enrollment.
Time frame: Minimum 12 months up to 48 months
Clinical symptoms (changes in other UHDRS scores); safety (frequency of adverse events); tolerability (proportion of subjects completing study at assigned dosage level), quality of life, other biological markers.
Time frame: Duration of the trial
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University of South Florida
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
...and 37 more locations