Phase 2
N=10
Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
Huntington Disease
Bottom Line
View on ClinicalTrials.gov: NCT03515213 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Change in PGC-1alpha RNA Expression — -0.02190716; 0.3160562; 0.07414876; 0.4800263 Log 2 fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fenofibrate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PGC-1alpha RNA Expression |
-0.02190716; 0.3160562; 0.07414876; 0.4800263 | — |
| PRIMARY Change in PGC-1alpha Protein Abundance. |
0.2609123; -0.02029792; 0.02375246; 0.3185422 | — |
| SECONDARY Change in Fenofibric Acid Level. |
64; 5; 9037; 10; 10905; 19 | — |
| SECONDARY Change in Unified Huntington Disease Rating Scale Motor Score. |
19.56; 34; 21.22; 27 | — |
| SECONDARY Change in Montreal Cognitive Assesment Score. |
24.222; 18; 25.778; 16; 25.667; 22 | — |
| SECONDARY Changes in Unified Huntington Disease Rating Scale - Behavioral |
9.778; 8; 8.333; 9; 8.444; 8 | — |
| SECONDARY Change in Functional Assessment Scores |
3.222; 3; 3.571; 3; 3.571; 3 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03515213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.