Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
- Registration Number
- NCT00712426
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 553
- Male or female ages 18 or older.
- Clinical features of HD AND confirmatory family history of HD; OR Clinical features of HD AND CAG repeat expansion greater or equal to 36.
- Stage I or II of illness (TFC greater or equal to 7).
- Ambulatory and not requiring skilled nursing care at the time of enrollment.
- Must be capable of providing informed consent and complying with trial procedures.
- Additional inclusion criteria apply.
- History of known sensitivity or intolerability to creatine monohydrate.
- Exposure to any investigational drug within 30 days of randomization (Baseline visit).
- Use of supplemental creatine at a dose greater than 10 grams within 30 days of randomization (Baseline visit).
- Screening laboratory abnormalities that in the judgment of the investigator would jeopardize safe conduct of study.
- Clinical evidence of unstable medical illness.
- Clinical evidence of unstable psychiatric illness.
- Additional exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Creatine Monohydrate Randomized to receive creatine monohydrate (up to 40 grams daily) B Placebo Randomized to receive placebo (up to 40 grams daily)
- Primary Outcome Measures
Name Time Method Change in Total Functional Capacity Minimum 12 months up to 48 months Study duration depends on each subject's calendar date of enrollment.
- Secondary Outcome Measures
Name Time Method 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. Duration of the trial
Trial Locations
- Locations (47)
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
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
Scroll for more (37 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States