Trial record 33 of 182 for:    "huntington disease"

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

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: NCT01412151
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : December 28, 2012
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Huntington's Disease (HD) Drug: Creatine monohydrate Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : April 2005
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Creatine monohydrate
single arm long-term open label follow-up
Drug: Creatine monohydrate
Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
Other Name: creatine, crea-pure

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

Secondary Outcome Measures :
  1. Clinical Measures Resources Not Available to Complete Secondary Analyses. [ Time Frame: 310 Weeks ]

    Components of the UHDRS (Unified Huntington Disease Rating Scale)

    data was not collected or analyzed for this outcome measure.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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): 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


Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital Identifier: NCT01412151     History of Changes
Other Study ID Numbers: 2005P000530
First Posted: August 9, 2011    Key Record Dates
Results First Posted: December 28, 2012
Last Update Posted: March 9, 2018
Last Verified: February 2018

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