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Premanifest Huntington's Disease Extension Study II: Creatine Safety & Tolerability (Pre-CREST-2X)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411163
First Posted: August 8, 2011
Last Update Posted: February 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital
August 4, 2011
August 8, 2011
February 10, 2014
April 2010
May 2013   (Final data collection date for primary outcome measure)
  • Safety [ Time Frame: 24 months ]
    Frequency of adverse events
  • Tolerability [ Time Frame: 24 months ]
    Proportion of subjects completing the extension study at given dose level
Same as current
Complete list of historical versions of study NCT01411163 on ClinicalTrials.gov Archive Site
  • Clinical measures [ Time Frame: 24 months ]
    Components of the UHDRS (Unified Huntington Disease Rating Scale)
  • Biological Markers of Disease Progression [ Time Frame: 24 months ]
    Biological indicators that creatine treatment might affect the progression of HD: plasma levels of creatine, serum levels of 8OH2'dG and 8OHG, magnetic resonance imaging (MRI), morphometric neuroimaging (biomarker of neurodegeneration), metabolomic profiling, and gene expression analysis to assess transcriptional effects of HD and creatine therapy.
  • Clinical measures [ Time Frame: 24 months ]
    Components of the UHDRS (Unitifed Huntington Disease Rating Scale)
  • Biological Markers of Disease Progression [ Time Frame: 24 months ]
    Biological indicators that creatine treatment might affect the progression of HD: plasma levels of creatine, serum levels of 8OH2'dG and 8OHG, magnetic resonance imaging (MRI), morphometric neuroimaging (biomarker of neurodegeneration), metabolomic profiling, and gene expression analysis to assess transcriptional effects of HD and creatine therapy.
Not Provided
Not Provided
 
Premanifest Huntington's Disease Extension Study II: Creatine Safety & Tolerability
Premanifest Huntington's Disease Extension Study II: Creatine Safety & Tolerability
The purpose of this clinical trial is to extend the Pre-Crest-X study to further assess the long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in symptomatic individuals are informative in premanifest individuals over a longer duration.
Extensive evidence exists that neurodegeneration begins many years before HD can be diagnosed clinically. Therefore, it is most desirable to begin a neuroprotective therapy before or during this premanifest period with the aim of delaying onset, as well as slowing functional decline. Cellular energy depletion is present early in HD and can be ameliorated by creatine, which helps regenerate cellular ATP. Preclinical evidence for creatine's potential neuroprotective effects in animal models of HD has been well-documented. Before the clinical efficacy of creatine can be tested in premanifest HD, its long-term safety and tolerability must be assessed in these individuals and its ability to favorably modify biomarkers of HD should also be confirmed. This extension trial will continue to follow eligible individuals who completed the Pre-CREST-X extension study on open-label creatine (up to 30 grams daily) for long term safety and tolerability for an additional 24 months. Other biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Huntington's Disease
Drug: Creatine monohydrate
Up to 30 grams daily creatine monohydrate
Experimental: Creatine
Intervention: Drug: Creatine monohydrate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals who have completed the Pre-CREST Study.
  • Individuals capable of providing independent informed consent and complying with trial procedures.

Exclusion Criteria:

-Clinical evidence of unstable medical or psychiatric illness in the investigator's judgment.

Additional eligibility criteria apply.

Sexes Eligible for Study: All
26 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01411163
2010P000511
Yes
Not Provided
Not Provided
Steven M. Hersch, Massachusetts General Hospital
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Diana Rosas, MD, MS Massachusetts General Hospital
Massachusetts General Hospital
January 2014

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