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



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2009
End Date:January 2015

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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.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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6701 Country Club Drive
Golden Valley, Minnesota 55427
888-993-5495
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
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Birmingham, Alabama 35294
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Farmington, Connecticut 06030
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Irvine, California 92697
949-824-5011
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Manhasset, New York 11030
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Wentworthville, New South Wales 2145
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Winston Salem, North Carolina 27157
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