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Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease

NCT03515213•University of California, Irvine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

University of California, Irvine

Irvine, California, United States

Key Dates

Start Date

April 27, 2017

Primary Completion Date

August 31, 2021

Completion Date

August 31, 2021

Last Updated

September 28, 2023

Enrollment

ACTUAL participants

Conditions

Huntington Disease

Interventions

Fenofibrate

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BDNF Pathway Biomarkers in the Cerebrospinal Fluid in Patients With Huntington's Disease

Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD)

A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD

IMarkHD: in Vivo Longitudinal Imaging of HD Pathology

Gene Therapy Development and Validation for Huntington's Disease Fibro TG-HD

GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease