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Trial record 33 of 193 for:    "huntington disease"

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

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.
 
ClinicalTrials.gov Identifier: NCT01411150
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 4, 2011
First Posted Date  ICMJE August 8, 2011
Last Update Posted Date February 10, 2014
Study Start Date  ICMJE May 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
  • Safety [ Time Frame: 12 months ]
    Frequency of adverse events
  • Tolerability [ Time Frame: 12 months ]
    Proportion of subjects completing the extension study at given dose level
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01411150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
  • Clinical measures [ Time Frame: 12 months ]
    Components of the UHDRS (United Huntington's Disease Rating Scale)
  • Biological Markers of Disease Progression [ Time Frame: 12 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
  • Clinical measures [ Time Frame: 12 months ]
    Components of the UHDRS (Unitifed Huntington Disease Rating Scale)
  • Biological Markers of Disease Progression [ Time Frame: 12 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study
Official Title  ICMJE Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study
Brief Summary The purpose of this clinical trial is to extend the Pre-Crest study (Protocol # (NCT00592995) 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.
Detailed Description 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 PreCREST study on open-label creatine (up to 30 grams daily) for long term safety and tolerability. Additional biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Drug: Creatine Monohydrate
Up to 30 grams daily creatine monohydrate
Study Arms  ICMJE Experimental: Creatine
Intervention: Drug: Creatine Monohydrate
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2013)
38
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2011)
60
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 26 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01411150
Other Study ID Numbers  ICMJE 2009P000642
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven M. Hersch, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Diana Rosas, MD, MS Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2014

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