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Completed

NCT Number: NCT03515213

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

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Irvine

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fenofibrate

Drug

145mg of fenofibrate

Placebo

Drug

Placebo

Primary outcomes

  1. Change in PGC-1alpha RNA Expression

    Time frame: Baseline compared to 3 and 6 months.

    Change in PGC-1alpha RNA expression from Baseline, Month 3 and Month 6

  2. Change in PGC-1alpha Protein Abundance.

    Time frame: Baseline compared to 3 and 6 months.

    Mean change in PGC-1alpha protein abundance.

Secondary outcomes

  1. Change in Fenofibric Acid Level.

    Time frame: Baseline to 3 and 6 months.

    Change in Fenofibric acid abundance from Baseline to 3 and 6 months.

  2. Change in Unified Huntington Disease Rating Scale Motor Score.

    Time frame: Baseline and 6 months

    Unified Huntington Disease Rating Scale (UHDRS) Motor (total score range 0-124 where higher score = greater impairment)

  3. Change in Montreal Cognitive Assesment Score.

    Time frame: Baseline compared to 3 and 6 months.

    Montreal Cognitive Assessment (total score range 0-30, higher score = less impairment)

  4. Changes in Unified Huntington Disease Rating Scale - Behavioral

    Time frame: Baseline, Month 3 and 6 months

    Unified Huntington Disease Rating Scale (UHDRS) Behavioral Scale (total score range 0-100 where 100 = 100% independent)

  5. Change in Functional Assessment Scores

    Time frame: Baseline compared to 3 and 6 months.

    Clinical Global Impression (CGI-I); (total score range 1-7 where higher score = greater impairment), and Unified Huntington Disease Rating Scale (UHDRS) Total Functional Capacity Assessment ( total score range 0-13, higher score = less impairment)

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 3, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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