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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00712426
Collaborator
University of Rochester (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)
553
Enrollment
47
Locations
2
Arms
64
Duration (Months)
11.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Creatine Monohydrate
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
553 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Dextrose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total Functional Capacity [Minimum 12 months up to 48 months]

      Study duration depends on each subject's calendar date of enrollment.

    Secondary Outcome Measures

    1. 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. [Duration of the trial]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35294
    2 University of California, Irvine Irvine California United States 92697
    3 University of California Davis Sacramento California United States 95817
    4 University of Connecticut Farmington Connecticut United States 06030
    5 University of Florida (McKnight Brain Institute) Gainesville Florida United States 32610
    6 University of South Florida Tampa Florida United States 33612
    7 Emory University School of Medicine Atlanta Georgia United States 30329
    8 Georgia Regents University Augusta Georgia United States 30329
    9 Rush University Medical Center Chicago Illinois United States 60612
    10 Indiana University Indianapolis Indiana United States 27157
    11 University of Iowa Iowa City Iowa United States 52242
    12 University of Kansas Medical Center Kansas City Kansas United States 66160
    13 Hereditary Neurological Disease Center (HNDC) Wichita Kansas United States 67206
    14 University of Louisville Louisville Kentucky United States 40202
    15 University of Maryland School of Medicine Baltimore Maryland United States 21201
    16 Massachusetts General Hospital Boston Massachusetts United States 02129
    17 University of Michigan Ann Arbor Michigan United States 48109
    18 Struthers Parkinson's Center Golden Valley Minnesota United States 55427
    19 Washington University School of Medicine Saint Louis Missouri United States 63110
    20 Nebraska Medical Center Omaha Nebraska United States 68198
    21 Cooper University Hospital Camden New Jersey United States 08103
    22 Albany Medical College Albany New York United States 12208
    23 North Shore-LIJ Health System Manhasset New York United States 11030
    24 Columbia University Medical Center New York New York United States 10032
    25 University of Rochester Rochester New York United States 14618
    26 Duke University Durham North Carolina United States 27705
    27 Wake Forest University School of Medicine Winston Salem North Carolina United States 27157
    28 University of Cincinnati Cincinnati Ohio United States 45267
    29 Cleveland Clinic Cleveland Ohio United States 44195
    30 Ohio State University Columbus Ohio United States 43210
    31 University of Pennsylvania Philadelphia Pennsylvania United States 19107
    32 University of Pittsburgh Pittsburgh Pennsylvania United States 15260
    33 Medical University of South Carolina Charleston South Carolina United States 29425
    34 University of Tennessee Health Science Center Memphis Tennessee United States 38163
    35 Baylor College of Medicine Houston Texas United States 77030
    36 University of Utah Salt Lake City Utah United States 84108
    37 University of Virginia Health System Charlottesville Virginia United States 22908
    38 Booth Gardner Parkinson's Care Center (Evergreen Healthcare) Kirkland Washington United States 98034
    39 Westmead Hospital Wentworthville New South Wales Australia 2145
    40 Neurodegenerative Disorders Research Subiaco Western Australia Australia 6008
    41 University of Alberta Hospital Edmonton Alberta Canada T2N 4Z6
    42 University of Alberta Edmonton Alberta Canada T2N 4Z6
    43 Movement Disorder Clinic Deer Lodge Center Winnipeg Manitoba Canada R3J 2H7
    44 CHUM - Hopital Notre-Dame Montreal Quebec Canada H2L 4M1
    45 University of Quebec Infant-Jesus Hospital (Centre Hospitalier Affilie) Quebec City Quebec Canada G1J 1Z4
    46 Auckland City Hospital Auckland New Zealand 1142
    47 New Zealand Brain Research Institute Christchurch New Zealand 8011

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • University of Rochester
    • National Center for Complementary and Integrative Health (NCCIH)

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT00712426
    Other Study ID Numbers:
    • 2007P000827
    • U01AT000613
    First Posted:
    Jul 10, 2008
    Last Update Posted:
    Mar 11, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
    Huntington's disease
    Creatine
    Mitochondrial Dysfunction
    Total Functional Capacity
    UHDRS
    Additional relevant MeSH terms:
    Huntington Disease

    Study Results

    No Results Posted as of Mar 11, 2016