Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
21 participants
INTERVENTIONAL
2007-08-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
NCT03515213
Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
NCT01019473
Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The "UP" Study
NCT03840005
A Study to Evaluate the Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD)
NCT05358717
Riluzole in Huntington's Disease
NCT00277602
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. To establish whether treatment with the drug ursodiol will result in measurable levels of its bile acid metabolites in serum and CSF at standard oral doses; and whether a dose-response can be detected using these measures.
2. To establish a preliminary safety and tolerability profile of the drug in subjects with HD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
ursodiol
ursodiol 300 mg twice daily for study days 0 through 28
ursodiol 600mg twice daily on study days 0 through 28
B
ursodiol
ursodiol 300 mg twice daily for study days 0 through 28
ursodiol 600mg twice daily on study days 0 through 28
C
placebo
placebo 600mg twice daily for study days 0 through 28
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ursodiol
ursodiol 300 mg twice daily for study days 0 through 28
ursodiol 600mg twice daily on study days 0 through 28
placebo
placebo 600mg twice daily for study days 0 through 28
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huntington Study Group
NETWORK
Huntington Society of Canada
OTHER
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Oregon Health & Science University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Penelope Hogarth, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health & Science University
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Keene 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00001927
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.