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Trial record 3 of 5 for:    crest-2

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

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. Identifier: NCT01411163
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : February 10, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Creatine monohydrate Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Premanifest Huntington's Disease Extension Study II: Creatine Safety & Tolerability
Study Start Date : April 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Creatine Drug: Creatine monohydrate
Up to 30 grams daily creatine monohydrate

Primary Outcome Measures :
  1. Safety [ Time Frame: 24 months ]
    Frequency of adverse events

  2. Tolerability [ Time Frame: 24 months ]
    Proportion of subjects completing the extension study at given dose level

Secondary Outcome Measures :
  1. Clinical measures [ Time Frame: 24 months ]
    Components of the UHDRS (Unified Huntington Disease Rating Scale)

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01411163

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United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
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Principal Investigator: Diana Rosas, MD, MS Massachusetts General Hospital

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Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital Identifier: NCT01411163    
Other Study ID Numbers: 2010P000511
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: January 2014
Keywords provided by Steven M. Hersch, Massachusetts General Hospital:
Huntington's Disease
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders