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 |
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.
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
39
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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University of Utah Research is a major component in the life of the U benefiting...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
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University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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University of Louisville The University of Louisville is a state supported research university located in...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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University of California-Davis As we begin our second century, UC Davis is poised to become...
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660 S Euclid Ave
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Saint Louis, Missouri 63110
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