NCT00712426

Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 553 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
DRUG	Creatine Monohydrate	Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
DRUG	Placebo	Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2008-07-10
• Last updated: 2016-03-11

Locations

47 sites across 4 countries: United States, Australia, Canada, New Zealand