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

This study is currently recruiting participants.
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Collaborators:
University of Rochester
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00712426
First received: July 8, 2008
Last updated: March 21, 2013
Last verified: March 2013
History of Changes

July 8, 2008
March 21, 2013
September 2009
June 2016   (final data collection date for primary outcome measure)
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00712426 on ClinicalTrials.gov Archive Site
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 ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Huntington's Disease
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female ages 18 or older.
  • Clinical features of HD AND confirmatory family history of HD; OR 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.
Both
18 Years and older
No
Contact: Huntington Study Group 1-800-487-7671
United States,   Australia,   Canada,   New Zealand
 
NCT00712426
2007P000827, U01AT000613
Yes
Steven M. Hersch, Massachusetts General Hospital
Massachusetts General Hospital
  • University of Rochester
  • National Center for Complementary and Alternative Medicine (NCCAM)
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
Massachusetts General Hospital
March 2013

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