Status:
TERMINATED
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Huntington's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 effectiv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
553 Patients enrolled
Trial Details
Trial ID
NCT00712426
Start Date
September 1 2009
End Date
January 1 2015
Last Update
March 11 2016
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California, Irvine
Irvine, California, United States, 92697
3
University of California Davis
Sacramento, California, United States, 95817
4
University of Connecticut
Farmington, Connecticut, United States, 06030