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Trial record 1 of 585 for:    CREST-E
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Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Rochester
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00712426
First received: July 8, 2008
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Huntington's Disease
Drug: Creatine Monohydrate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Total Functional Capacity [ Time Frame: Minimum 12 months up to 48 months ] [ Designated as safety issue: No ]
    Study duration depends on each subject's calendar date of enrollment.


Secondary Outcome Measures:
  • Clinical symptoms (changes in other UHDRS scores); safety (frequency of adverse events); tolerability (proportion of subjects completing study at assigned dosage level), quality of life, other biological markers. [ Time Frame: Duration of the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Randomized to receive creatine monohydrate (up to 40 grams daily)
Drug: Creatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
Other Name: HD-02
Placebo Comparator: B
Randomized to receive placebo (up to 40 grams daily)
Drug: Placebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Other Name: Dextrose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712426

  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California, Irvine
Irvine, California, United States, 92697
University of California Davis
Sacramento, California, United States, 95817
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
United States, Florida
University of Florida (McKnight Brain Institute)
Gainesville, Florida, United States, 32610
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
Georgia Regents University
Augusta, Georgia, United States, 30329
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 27157
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Hereditary Neurological Disease Center (HNDC)
Wichita, Kansas, United States, 67206
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Struthers Parkinson's Center
Golden Valley, Minnesota, United States, 55427
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Albany Medical College
Albany, New York, United States, 12208
North Shore-LIJ Health System
Manhasset, New York, United States, 11030
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14618
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Booth Gardner Parkinson's Care Center (Evergreen Healthcare)
Kirkland, Washington, United States, 98034
Australia, New South Wales
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Western Australia
Neurodegenerative Disorders Research
Subiaco, Western Australia, Australia, 6008
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, Canada, T2N 4Z6
Canada, Manitoba
Movement Disorder Clinic Deer Lodge Center
Winnipeg, Manitoba, Canada, R3J 2H7
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
University of Quebec Infant-Jesus Hospital (Centre Hospitalier Affilie)
Quebec City, Quebec, Canada, G1J 1Z4
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1142
New Zealand Brain Research Institute
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Massachusetts General Hospital
University of Rochester
Investigators
Principal Investigator: Steven M Hersch, MD, PhD Massachusetts General Hospital
Principal Investigator: Giovanni Schifitto, MD University of Rochester Clinical Trial Coordination Center
Principal Investigator: Diana Rosas, MD, MS Massachusetts General Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00712426     History of Changes
Other Study ID Numbers: 2007P000827, U01AT000613
Study First Received: July 8, 2008
Last Updated: November 10, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
New Zealand: Food Safety Authority
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees
New Zealand: Institutional Review Board
New Zealand: Medsafe

Keywords provided by Massachusetts General Hospital:
Huntington's disease
Creatine
Mitochondrial Dysfunction
Total Functional Capacity
UHDRS

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Chorea
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on November 27, 2014