Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
NCT ID: NCT00712426
Last Updated: 2016-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
553 participants
INTERVENTIONAL
2009-09-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Randomized to receive creatine monohydrate (up to 40 grams daily)
Creatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
B
Randomized to receive placebo (up to 40 grams daily)
Placebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Interventions
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Creatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
Placebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Steven M. Hersch
Professor of Neurology
Principal Investigators
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Steven M Hersch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Giovanni Schifitto, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Clinical Trial Coordination Center
Diana Rosas, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Duke University
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Booth Gardner Parkinson's Care Center (Evergreen Healthcare)
Kirkland, Washington, United States
Westmead Hospital
Wentworthville, New South Wales, Australia
Neurodegenerative Disorders Research
Subiaco, Western Australia, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Movement Disorder Clinic Deer Lodge Center
Winnipeg, Manitoba, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
University of Quebec Infant-Jesus Hospital (Centre Hospitalier Affilie)
Québec, Quebec, Canada
Auckland City Hospital
Auckland, , New Zealand
New Zealand Brain Research Institute
Christchurch, , New Zealand
Countries
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References
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Kim J, Amante DJ, Moody JP, Edgerly CK, Bordiuk OL, Smith K, Matson SA, Matson WR, Scherzer CR, Rosas HD, Hersch SM, Ferrante RJ. Reduced creatine kinase as a central and peripheral biomarker in Huntington's disease. Biochim Biophys Acta. 2010 Jul-Aug;1802(7-8):673-81. doi: 10.1016/j.bbadis.2010.05.001. Epub 2010 May 9.
Hersch SM, Gevorkian S, Marder K, Moskowitz C, Feigin A, Cox M, Como P, Zimmerman C, Lin M, Zhang L, Ulug AM, Beal MF, Matson W, Bogdanov M, Ebbel E, Zaleta A, Kaneko Y, Jenkins B, Hevelone N, Zhang H, Yu H, Schoenfeld D, Ferrante R, Rosas HD. Creatine in Huntington disease is safe, tolerable, bioavailable in brain and reduces serum 8OH2'dG. Neurology. 2006 Jan 24;66(2):250-2. doi: 10.1212/01.wnl.0000194318.74946.b6.
Ryu H, Rosas HD, Hersch SM, Ferrante RJ. The therapeutic role of creatine in Huntington's disease. Pharmacol Ther. 2005 Nov;108(2):193-207. doi: 10.1016/j.pharmthera.2005.04.008. Epub 2005 Aug 1.
Dedeoglu A, Kubilus JK, Yang L, Ferrante KL, Hersch SM, Beal MF, Ferrante RJ. Creatine therapy provides neuroprotection after onset of clinical symptoms in Huntington's disease transgenic mice. J Neurochem. 2003 Jun;85(6):1359-67. doi: 10.1046/j.1471-4159.2003.01706.x.
Andreassen OA, Dedeoglu A, Ferrante RJ, Jenkins BG, Ferrante KL, Thomas M, Friedlich A, Browne SE, Schilling G, Borchelt DR, Hersch SM, Ross CA, Beal MF. Creatine increase survival and delays motor symptoms in a transgenic animal model of Huntington's disease. Neurobiol Dis. 2001 Jun;8(3):479-91. doi: 10.1006/nbdi.2001.0406.
Ferrante RJ, Andreassen OA, Jenkins BG, Dedeoglu A, Kuemmerle S, Kubilus JK, Kaddurah-Daouk R, Hersch SM, Beal MF. Neuroprotective effects of creatine in a transgenic mouse model of Huntington's disease. J Neurosci. 2000 Jun 15;20(12):4389-97. doi: 10.1523/JNEUROSCI.20-12-04389.2000.
McGarry A, Auinger P, Kieburtz KD, Bredlau AL, Hersch SM, Rosas HD. Suicidality Risk Factors Across the CARE-HD, 2CARE, and CREST-E Clinical Trials in Huntington Disease. Neurol Clin Pract. 2022 Apr;12(2):131-138. doi: 10.1212/CPJ.0000000000001161.
Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: August 2018. J Huntingtons Dis. 2018;7(3):279-286. doi: 10.3233/JHD-189003.
Hersch SM, Schifitto G, Oakes D, Bredlau AL, Meyers CM, Nahin R, Rosas HD; Huntington Study Group CREST-E Investigators and Coordinators. The CREST-E study of creatine for Huntington disease: A randomized controlled trial. Neurology. 2017 Aug 8;89(6):594-601. doi: 10.1212/WNL.0000000000004209. Epub 2017 Jul 12.
Other Identifiers
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2007P000827
Identifier Type: -
Identifier Source: org_study_id
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