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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00514774 |
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Date of registration:
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08/08/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ursodiol in Huntington's Disease
UDCA-HD |
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Scientific title:
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Ursodiol in Huntington's Disease |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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21 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00514774 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Penelope Hogarth, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All subjects will be age 18 or older
- All subjects will have manifest Huntington disease determined by clinical exam plus
either documented prior DNA testing for the HD gene or a documented family history
of the disease
Exclusion Criteria:
- Subjects taking oral contraceptives, cholestyramine, colestipol, or aluminum-based
antacids will be excluded
- Subjects with known allergy or other contraindication to the study drug will be
excluded
- Subjects with bleeding diathesis, or on coumadin or mandatory aspirin will be
excluded
- Subjects with unstable medical or psychiatric illness will be excluded
- Subjects with clinically significant lab / EKG abnormalities at screening will be
excluded
- Subjects who are currently pregnant or breastfeeding will be excluded
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Huntington Disease
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Intervention(s)
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Drug: placebo
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Drug: ursodiol
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Primary Outcome(s)
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Pharmacokinetic measures (Serum and CSF levels of bile acids)
[Time Frame: 28 days]
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Tolerability measures (adverse event severity)
[Time Frame: 35 days]
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Safety measures (complete blood count, chemistry profile, electrocardiogram, urinalysis)
[Time Frame: 35 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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