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

This study has been completed.
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital Identifier:
First received: August 5, 2011
Last updated: July 9, 2013
Last verified: July 2013
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: Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Steven M. Hersch, Massachusetts General Hospital:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 306 Weeks ]
    Proportion of subjects able to complete treatment

Secondary Outcome Measures:
  • Clinical Measures [ Time Frame: 310 Weeks ]
    Components of the UHDRS (Unified Huntington Disease Rating Scale)

  • Biological Markers of Disease Progression [ Time Frame: 310 Weeks ]
    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


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

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
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 identifier: NCT01412151

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


Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital Identifier: NCT01412151     History of Changes
Other Study ID Numbers: 2005P000530
Study First Received: August 5, 2011
Results First Received: November 28, 2012
Last Updated: July 9, 2013

Keywords provided by Steven M. Hersch, Massachusetts General Hospital:
Huntington's Disease

Additional relevant MeSH terms:
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
Dyskinesias processed this record on September 20, 2017