Ursodiol in Huntington's Disease (UDCA-HD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Huntington Study Group
Huntington Society of Canada
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00514774
First received: August 8, 2007
Last updated: February 4, 2009
Last verified: February 2009

August 8, 2007
February 4, 2009
August 2007
June 2009   (final data collection date for primary outcome measure)
  • Safety measures (complete blood count, chemistry profile, electrocardiogram, urinalysis) [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Tolerability measures (adverse event severity) [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic measures (Serum and CSF levels of bile acids) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Safety measures (complete blood count, chemistry profile, electrocardiogram, urinalysis) [ Time Frame: 35 days ]
  • Tolerability measures (adverse event severity) [ Time Frame: 35 days ]
  • Pharmacokinetic measures (Serum and CSF levels of bile acids) [ Time Frame: 28 days ]
Complete list of historical versions of study NCT00514774 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ursodiol in Huntington's Disease
Ursodiol in Huntington's Disease

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.

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:

  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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Huntington Disease
  • Drug: ursodiol

    ursodiol 300 mg twice daily for study days 0 through 28

    ursodiol 600mg twice daily on study days 0 through 28

    Other Names:
    • Ursodeoxycholic acid
    • UDCA
  • Drug: placebo
    placebo 600mg twice daily for study days 0 through 28
  • Experimental: A
    Intervention: Drug: ursodiol
  • Experimental: B
    Intervention: Drug: ursodiol
  • Placebo Comparator: C
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00514774
00001927
Yes
Penelope Hogarth, MD, Oregon Health & Science University
Oregon Health and Science University
  • Huntington Study Group
  • Huntington Society of Canada
Principal Investigator: Penelope Hogarth, M.D. Oregon Health and Science University
Oregon Health and Science University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP