NCT03515213已完成2 期
A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in PGC-1alpha RNA Expression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active
Active Comparator
干预措施: Fenofibrate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in PGC-1alpha RNA Expression
时间窗: Baseline compared to 3 and 6 months.
Change in PGC-1alpha RNA expression from Baseline, Month 3 and Month 6
Change in PGC-1alpha Protein Abundance.
时间窗: Baseline compared to 3 and 6 months.
Mean change in PGC-1alpha protein abundance.
次要结局
- Change in Functional Assessment Scores(Baseline compared to 3 and 6 months.)
- Change in Fenofibric Acid Level.(Baseline to 3 and 6 months.)
- Change in Unified Huntington Disease Rating Scale Motor Score.(Baseline and 6 months)
- Change in Montreal Cognitive Assesment Score.(Baseline compared to 3 and 6 months.)
- Changes in Unified Huntington Disease Rating Scale - Behavioral(Baseline, Month 3 and 6 months)
研究者
Leslie Thompson
Professor
University of California, Irvine
研究点 (1)
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