Study:
Creatine Safety, Tolerability, & Efficacy in Huntington`s Disease (CREST-E)
Rationale:
n/a
Purpose:
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 Status: Recruiting
Recruiting:
Jennifer Mule 216-444-1134 mulej@ccf.org
| Condition |
Intervention |
Phase |
|
Huntington`s Disease |
Drug: Creatine Monohydrate
Drug: Placebo |
Phase 3 |
Verified by
Massachusetts General Hospital
March, 2013
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov identifier: NCT00712426
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Steven M Hersch, MD, PhD., Principal Investigator
Giovanni Schifitto, MD., Principal Investigator
Diana Rosas, MD, MS., Principal Investigator