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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00514774
Date of registration: 08/08/2007
Prospective Registration: Yes
Primary sponsor: Oregon Health and Science University
Public title: Ursodiol in Huntington's Disease UDCA-HD
Scientific title: Ursodiol in Huntington's Disease
Date of first enrolment: August 2007
Target sample size: 21
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00514774
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Penelope Hogarth, M.D.
Address: 
Telephone:
Email:
Affiliation:  Oregon Health and Science University
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Huntington Disease
Intervention(s)
Drug: placebo
Drug: ursodiol
Primary Outcome(s)
Pharmacokinetic measures (Serum and CSF levels of bile acids) [Time Frame: 28 days]
Safety measures (complete blood count, chemistry profile, electrocardiogram, urinalysis) [Time Frame: 35 days]
Tolerability measures (adverse event severity) [Time Frame: 35 days]
Secondary Outcome(s)
Secondary ID(s)
00001927
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Huntington Society of Canada
Huntington Study Group
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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