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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
University of Rochester
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00712426
First received: July 8, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Huntington's Disease
Drug: Creatine Monohydrate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 650
Study Start Date: September 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712426

Contacts
Contact: Huntington Study Group 1-800-487-7671

  Show 53 Study Locations
Sponsors and Collaborators
Massachusetts General Hospital
University of Rochester
Investigators
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

Additional Information:
Publications:

Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00712426     History of Changes
Other Study ID Numbers: 2007P000827, U01AT000613
Study First Received: July 8, 2008
Last Updated: May 13, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
New Zealand: Food Safety Authority
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees
New Zealand: Institutional Review Board
New Zealand: Medsafe

Keywords provided by Massachusetts General Hospital:
Huntington's disease
Creatine
Mitochondrial Dysfunction
Total Functional Capacity
UHDRS

Additional relevant MeSH terms:
Chorea
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014