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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Huntington's Disease

In brief

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.

Key facts

Study ID

NCT00712426

Run by

Massachusetts General Hospital

People needed

553

Starts

2009-09-01

Expected to finish

2015-01-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Hereditary Neurological Disease Center (HNDC) — Wichita, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• North Shore-LIJ Health System — Manhasset, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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