Ursodiol in Huntington's Disease
UDCA-HD
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is processed by the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFebruary 5, 2009
February 1, 2009
1.8 years
August 8, 2007
February 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety measures (complete blood count, chemistry profile, electrocardiogram, urinalysis)
35 days
Tolerability measures (adverse event severity)
35 days
Pharmacokinetic measures (Serum and CSF levels of bile acids)
28 days
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Huntington Study Groupcollaborator
- Huntington Society of Canadacollaborator
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (2)
Keene CD, Rodrigues CM, Eich T, Chhabra MS, Steer CJ, Low WC. Tauroursodeoxycholic acid, a bile acid, is neuroprotective in a transgenic animal model of Huntington's disease. Proc Natl Acad Sci U S A. 2002 Aug 6;99(16):10671-6. doi: 10.1073/pnas.162362299. Epub 2002 Jul 29.
PMID: 12149470BACKGROUNDKeene CD, Rodrigues CM, Eich T, Linehan-Stieers C, Abt A, Kren BT, Steer CJ, Low WC. A bile acid protects against motor and cognitive deficits and reduces striatal degeneration in the 3-nitropropionic acid model of Huntington's disease. Exp Neurol. 2001 Oct;171(2):351-60. doi: 10.1006/exnr.2001.7755.
PMID: 11573988BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penelope Hogarth, M.D.
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 10, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
February 5, 2009
Record last verified: 2009-02