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Creatine Safety & Tolerability in Huntington's Disease (CREST-X)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01412151
First received: August 5, 2011
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to extend findings from the creatine dose-finding study (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and clinical impact of high dose creatine.


Condition Intervention Phase
Huntington's Disease (HD)
 Drug: Creatine monohydrate
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Creatine Safety & Tolerability in Huntington's Disease (CREST-X): A Single-Center, Open-Label, Long-Term Safety & Tolerability Extension Study of Creatine in Subjects With HD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 306 Weeks ] [ Designated as safety issue: Yes ]
    Proportion of subjects able to complete treatment


Secondary Outcome Measures:
  • Clinical Measures [ Time Frame: 310 Weeks ] [ Designated as safety issue: No ]
    Components of the UHDRS (Unified Huntington Disease Rating Scale)

  • Biological Markers of Disease Progression [ Time Frame: 310 Weeks ] [ Designated as safety issue: No ]
    Biological indicators that creatine treatment might affect the progression of HD: serum creatine levels, neuroimaging, metabolomic and gene expression analysis


Enrollment: 10
Study Start Date: April 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creatine monohydrate Drug: Creatine monohydrate
Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who have completed the CREST-UP1 study.
  • Individuals who are able to take oral medication.
  • Individuals capable of providing informed consent and complying with trial procedures.

Exclusion Criteria:

  • History of known sensitivity or intolerability to creatine.
  • Clinical evidence of unstable medical illness in the investigator's judgment.

Additional eligibility criteria apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412151

Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Diana Rosas, MD, MS Massachusetts General Hospital
Principal Investigator: Steven M Hersch, MD, PhD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01412151     History of Changes
Other Study ID Numbers: 2005P000530
Study First Received: August 5, 2011
Results First Received: November 28, 2012
Last Updated: December 31, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Symptomatic
Huntington's Disease
HD

Additional relevant MeSH terms:
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013