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Creatine Safety, Tolerability, and Efficacy in Huntington's Disease (CREST-E) Study
(ClinicalTrials.gov identifier: NCT00712426)
Creatine has been shown to reduce brain shrinkage, 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 was shown to be safe, tolerable, and bioavailable to the brain. 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 will be studied in this Phase III study. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Approximately 50 active research centers globally will enroll 650 subjects.
Primary Outcome Measures:
- Change in Total Functional Capacity [Time Frame: Minimum 12 months up to 48 months ]
- Study duration depends on each subject's calendar date of enrollment.
Secondary Outcome Measures:
- 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.
Study Start Date:
Estimated Study Completion Date:
Estimated Primary Completion Date:
June 2016 (Final data collection date for primary outcome measure)
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Accepts Healthy Volunteers:
- Male or female ages 18 or older.
- Clinical features of HD AND confirmatory family history of HD; OR 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.
- 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.
Want more info?
Contact: Huntington Study Group at 1-800-487-7671, or visit