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

NCT ID: NCT03515213

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2021-08-31

Brief Summary

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.

Conditions

Huntington Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

Group Type: ACTIVE_COMPARATOR

Fenofibrate

Intervention Type: DRUG

145mg of fenofibrate

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Fenofibrate

145mg of fenofibrate

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Leslie Thompson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Hermanowicz, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Leslie Thompson, PhD

Role: STUDY_DIRECTOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20163022

Identifier Type: -

Identifier Source: org_study_id