Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01412151 |
Date of registration:
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05/08/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Creatine Safety & Tolerability in Huntington's Disease
CREST-X |
Scientific title:
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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 |
Date of first enrolment:
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April 2005 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01412151 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Diana Rosas, MD, MS |
Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Name:
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Steven M Hersch, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington's Disease (HD)
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Intervention(s)
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Drug: Creatine monohydrate
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Primary Outcome(s)
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Tolerability
[Time Frame: 306 Weeks]
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Secondary Outcome(s)
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Biological Markers of Disease Progression
[Time Frame: 310 Weeks]
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Clinical Measures Resources Not Available to Complete Secondary Analyses.
[Time Frame: 310 Weeks]
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Secondary ID(s)
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2005P000530
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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