Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease

University of California Irvine (UCI)

Status and phase: Completed; Phase 2

Conditions: Huntington Disease

Treatments: Drug: Fenofibrate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03515213

20163022

Details and patient eligibility

About

The purpose of this research study is to study the safety and efficacy of fenofibrate, an FDA-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment for Huntington's disease (HD). Subjects who meet the entry criteria will be randomized (3:1) to either 145mg of fenofibrate or placebo.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An adult of either sex, ages 25-85 inclusive,
• Have proficiency with written and spoken English and corrected vision or hearing to complete the cognitive testing,
• Are able to give informed consent,
• Have good overall health status with no known problems anticipated over the course of the trial,
• Have a diagnosis of HD supported by positive gene test within the past 6 months.

Exclusion criteria

• Other major neurological disease [e.g., multiple sclerosis, parkinson's disease, cortical stroke, etc]
• Clinically significant hepatic or renal disease,
• Current or recent (< 1 month) use of dopamine blocking agents such as tetrabenazine, anticonvulsants, neuroleptics, HAART, antiemetics, and antipsychotics for any reason,
• Current use of Warfarin (Coumadin). Enrollment in another investigational drug study within the prior three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Treatment:

Drug: Fenofibrate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo