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

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: 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Creatine Monohydrate Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 553 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Study Start Date : September 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Randomized to receive creatine monohydrate (up to 40 grams daily)
 Drug: Creatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
Other Name: HD-02
Placebo Comparator: B
Randomized to receive placebo (up to 40 grams daily)
 Drug: Placebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Other Name: Dextrose


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00712426


Locations
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Sponsors and Collaborators
Massachusetts General Hospital
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00712426    
Other Study ID Numbers: 2007P000827
U01AT000613 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: February 2016
Keywords provided by Steven M. Hersch, Massachusetts General Hospital:
Huntington's disease
Creatine
Mitochondrial Dysfunction
Total Functional Capacity
UHDRS
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders