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

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ClinicalTrials.gov Identifier: NCT00712426
Recruitment Status : Terminated (Results of an interim analysis showed that it was unlikely that creatine was effective in slowing loss of function in early symptomatic Huntington's Disease.)
First Posted : July 10, 2008
Last Update Posted : March 11, 2016
Sponsor:
Collaborators:
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 8, 2008
First Posted Date  ICMJE July 10, 2008
Last Update Posted Date March 11, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
To assess the effects of creatine monohydrate (HD-02) on the progression of functional decline in HD as measured by the change in the Total Functional Capacity (TFC) scale over 36 months. [ Time Frame: after approximately 163, 325, & 488 subjects have completed the study ]
Change History Complete list of historical versions of study NCT00712426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2008)
To assess the long-term safety and tolerability of creatine(HD-02) in HD, its effect on clinical symptoms, quality of life, and effect on biological outcome measures of HD progression as compared to placebo. [ Time Frame: after 50, 150, and 300 subjects have reached 12 months of follow-up and after 50% of the subjects have reached the 36 month visit ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Official Title  ICMJE Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE
  • Drug: Creatine Monohydrate
    Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
    Other Name: HD-02
  • Drug: Placebo
    Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
    Other Name: Dextrose
Study Arms
  • Active Comparator: A
    Randomized to receive creatine monohydrate (up to 40 grams daily)
    Intervention: Drug: Creatine Monohydrate
  • Placebo Comparator: B
    Randomized to receive placebo (up to 40 grams daily)
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
553
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2008)
650
Actual Study Completion Date January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712426
Other Study ID Numbers  ICMJE 2007P000827
U01AT000613 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Steven M. Hersch, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • University of Rochester
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
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
PRS Account Massachusetts General Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP