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

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ClinicalTrials.gov Identifier: NCT03515213
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Neal Hermanowicz, MD, University of California, Irvine

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 triglyerides (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.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: Fenofibrate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
Active Comparator: Active Drug: Fenofibrate
145mg of fenofibrate

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change in PGC-1alpha from Baseline to Month 6 [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]
    Change in PGC-1alpha from Baseline to Month 6


Secondary Outcome Measures :
  1. Change in Fenofibrate level from Baseline to Month 6 [ Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]
    Change in Fenofibrate level from Baseline to Month 6

  2. Change in Motor Scores from Baseline to Month 6 [ Time Frame: Baseline, 3 months, and 6 months ]
    Unified Huntington Disease Rating Scale (UHDRS) Motor (total score range 0-124 where higher score = greater impairment)

  3. Change in Cognition Scores from Baseline to Month 6 [ Time Frame: Baseline, 3 months, and 6 months ]
    Montreal Cognitive Assessment (total score range 0-30, higher score = less impairment), Stroop Word (cognitive interference measure, calculated interference score where higher = better performance), and Benton Judgement of Line Orientation (test of spatial thinking, total score range 0-30, higher score = better performance)

  4. Changes in Independence Assessment Scores from Baseline to Month 6 [ Time Frame: Baseline, 3 months, and 6 months ]
    Unified Huntington Disease Rating Scale (UHDRS) Independence Scale (total score range 0-100 where 100 = 100% independent)

  5. Change in Functional Assessment Scores from Baseline to Month 6 [ Time Frame: Baseline, 3 months, 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515213


Contacts
Contact: Everlyne Gomez, M.Sc. 9498248116 everlyng@uci.edu
Contact: Yuna Muyshondt, MPH 9498249621 chuny@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Everlyne Gomez    949-824-8116    everlyng@uci.edu   
Principal Investigator: Neal Hermanowicz, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Neal Hermanowicz, MD University of California, Irvine
Study Director: Leslie Thompson, PhD University of California, Irvine

Responsible Party: Neal Hermanowicz, MD, Health Sciences Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03515213     History of Changes
Other Study ID Numbers: 2016-3022
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents