Fenofibrate

Study Title:  A Phase IIA, Randomized, Double-blind, Placebo-controlled study of the safety and efficacy of fenofibrate as a treatment for Huntington’s Disease

Purpose: To study the safety and efficacy of fenofibrate, an FDA approved drug to treat cholesterol, as a treatment for Huntington’s disease (HD)

Study drug: 145mg of fenofibrate vs. placebo (75% chance of active drug; 25% chance of placebo)

Duration of study: 6 months with 8 in-clinic visits

Inclusion criteria:

  • Age 18 or older
  • Clinical findings of Huntington’s disease (HD) and a confirmed family history of HD
  • Clinical findings of HD and a CAG repeat of ≥ 36​
  • Good overall health status
  • Must be able to take oral medication

Exclusion criteria:

  • Diagnosis of another major neurological disease (e.g., multiple sclerosis, Parkinson’s disease, cortical stroke)
  • History of gallstones
  • History of known sensitivity to any fibrate medication
  • Exposure to another investigational medicine within 30 days prior to baseline visit
  • Current or recent (within 3 months of screening visit) use of dopamine blocking agents such as: tetrabenazine, antipsychotics, metoclopramide, prochlorperazine, or HAART
  • Current use of Warfarin (Coumadin)
  • Current use of statins (e.g., simvastatin, atorvastatin, etc.)
  • Are pregnant or lactating

Please note: the above may not be a complete list of inclusion and/or exclusion criteria

CLINICAL TRIALS CURRENTLY RECRUITING
Department of Neurology

Enroll-HD

Study Title:  A Prospective Registry Study in a Global Huntington’s Disease Cohort (A CHDI Foundation Project)

Purpose: To collect clinical information about subjects and their health. In addition, biological samples (DNA and blood) will be collected to learn more about HD and try to find new treatments for the disease.

Study drug: No study medication or device

Duration of study: No study medication or device

Inclusion criteria:

  • Age 18 or older
  • Carriers: individuals with the HD gene expansion mutation
  • Genotype Unknown: first or second degree relatives who have not undergone HD testing, and have an unknown carrier type
  • Family/Community Controls: individuals without HD or any family history of HD

Exclusion criteria:

  • Have choreic movement disorders in the context of a negative test for the HD mutation
  • For controls: history of concurrent major central nervous system (e.g., stroke, Parkinson’s disease, etc.)

Please note: the above may not be a complete list of inclusion and/or exclusion criteria

For more information, please contact the UC Irvine Neurology Clinical Trials Unit at one of the following:
(949) 824 – 3485
(949) 824 – 7524

Everlyne Gomez: everlyng@uci.edu

To seek information on other trials that may be available, contact:
Everlyne Gomez MSc
Senior Clinical Research Coordinator
Department of Neurology
University of California, Irvine
(949) 824-8116
everlyng@uci.edu