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

Huntington Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515213
• Other study ID #: 20163022
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• Fenofibrate
145mg of fenofibrate
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PGC-1alpha RNA Expression	Change in PGC-1alpha RNA expression from Baseline, Month 3 and Month 6	Baseline compared to 3 and 6 months.
Primary	Change in PGC-1alpha Protein Abundance.	Mean change in PGC-1alpha protein abundance.	Baseline compared to 3 and 6 months.
Secondary	Change in Fenofibric Acid Level.	Change in Fenofibric acid abundance from Baseline to 3 and 6 months.	Baseline to 3 and 6 months.
Secondary	Change in Unified Huntington Disease Rating Scale Motor Score.	Unified Huntington Disease Rating Scale (UHDRS) Motor (total score range 0-124 where higher score = greater impairment)	Baseline and 6 months
Secondary	Change in Montreal Cognitive Assesment Score.	Montreal Cognitive Assessment (total score range 0-30, higher score = less impairment)	Baseline compared to 3 and 6 months.
Secondary	Changes in Unified Huntington Disease Rating Scale - Behavioral	Unified Huntington Disease Rating Scale (UHDRS) Behavioral Scale (total score range 0-100 where 100 = 100% independent)	Baseline, Month 3 and 6 months
Secondary	Change in Functional Assessment Scores	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)	Baseline compared to 3 and 6 months.