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

February 10, 2016 updated by: Steven M. Hersch, Massachusetts General Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

553

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Functional Capacity
Time Frame: Minimum 12 months up to 48 months
Study duration depends on each subject's calendar date of enrollment.
Minimum 12 months up to 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Duration of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000827
  • U01AT000613 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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