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Sponsors and Collaborators: |
Oregon Health and Science University Huntington Study Group Huntington Society of Canada |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00514774 |
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.
Condition | Intervention | Phase |
---|---|---|
Huntington Disease |
Drug: ursodiol Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Ursodiol in Huntington's Disease |
Estimated Enrollment: | 21 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: ursodiol
ursodiol 300 mg twice daily for study days 0 through 28 ursodiol 600mg twice daily on study days 0 through 28 |
B: Experimental |
Drug: ursodiol
ursodiol 300 mg twice daily for study days 0 through 28 ursodiol 600mg twice daily on study days 0 through 28 |
C: Placebo Comparator |
Drug: placebo
placebo 600mg twice daily for study days 0 through 28
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Huntington's disease is an inherited neurodegenerative disease that causes a movement disorder, dementia, and psychiatric and behavioral disturbance in affected individuals.
Tauroursodeoxycholic acid (TUDCA) is a bile acid synthesized in the liver by the conjugation of taurine to ursodeoxycholic acid (UDCA). It is thought to function as an anti-apoptotic agent in HD, evidenced by studies in toxic cell models and both toxic and transgenic rodent models of the disease.
Ursodiol is a commercially-available exogenous form of UDCA, the precursor of TUDCA. Although the compound has an established dosing, safety, tolerability and efficacy profile in patients with hepatobiliary disorders, gaps exist in the understanding of the pharmacokinetics / pharmacodynamics of the compound, particularly in patients with normal gastrointestinal function, and no human data exist for its therapeutic use in neurodegenerative disorders. The specific aims of this study are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: April Wilson, B.A. | 503-418-1769 | wilsonap@ohsu.edu |
Contact: Penelope Hogarth, M.D. | 503-494-7230 |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: April Wilson, B.S. 503-418-1769 wilsonap@ohsu.edu | |
Contact: Pamela Andrews, B.A. 503-494-0965 andrewsp@ohsu.edu | |
Principal Investigator: Penelope Hogarth, M.D. |
Principal Investigator: | Penelope Hogarth, M.D. | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Penelope Hogarth, MD ) |
Study ID Numbers: | 00001927 |
Study First Received: | August 8, 2007 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00514774 |
Health Authority: | United States: Institutional Review Board |
Huntington chorea chorea hereditary tauroursodeoxycholic acid |
ursodeoxycholic acid TUDCA UDCA |
Ganglion Cysts Huntington disease Tauroursodeoxycholic acid Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders Ursodeoxycholic Acid |
Chorea Delirium, Dementia, Amnestic, Cognitive Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Dementia Huntington Disease Delirium |
Therapeutic Uses Cholagogues and Choleretics Nervous System Diseases Gastrointestinal Agents Pharmacologic Actions |