NCT00146211已完成3 期
A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 42
- 主要终点
- To compare with placebo the effect of ethyl-EPA on the Total Motor Score-4 component (TMS) of the Unified Huntington's Disease Rating Scale (UHDRS) over a 6-month period of observation.
研究概览
简要总结
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
详细描述
Multi-center, double blind, placebo-controlled study with parallel groups of outpatients with early, symptomatic Huntington's disease. Participants will be randomized to receive 1 gram twice daily (2 gram/day total daily dose) of active study drug or placebo. The 6-month placebo-controlled phased will be followed by a subsequent 6-month open-label extension phase with all subjects receiving 1 gram twice daily (2 grams/day total daily dose) of active study drug.
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
- Double
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical features of Huntington's disease (HD) and confirmatory family history of HD, and/or CAG repeat expansion greater than or equal to 36
- •Ambulatory, not requiring skilled nursing care (total functional capacity [TFC] greater than or equal to 7)
- •Chorea score of at least 2 in one extremity (UHDRS)
- •Maximal dystonia less than or equal to 2 and maximal bradykinesia less than or equal to 2
- •35 years of age or older of either gender
- •Must be on stable dosages of non-competitive NMDA receptor antagonists, and/or antiepileptic medications for 60 days prior to baseline
- •Females of child-bearing potential must use adequate birth control
排除标准
- •History of established diagnosis of tardive dyskinesia
- •Clinical evidence of unstable medical or psychiatric illness
- •Clinically significant active and unstable psychotic disease (hallucinations or delusions)
- •Major depression (Beck Depression Inventory [BDI]-II Score greater than 20) at Screening Visit
- •Suicidal ideation (BDI-II item 9 greater than or equal to 2) at Screening Visit
- •History of clinically significant substance abuse within 12 months of Baseline Visit
- •Pregnant/lactating women
- •Participation in other drug studies within 60 days prior to Baseline Visit
- •Previous participation in any investigational study of ethyl-EPA (Miraxion™)
- •Use of aspirin at daily dosage greater than 325 mg/day
- •Exclusionary Drugs (within 6 months Baseline Visit): Depot neuroleptics
- •Exclusionary Drugs (within 60 days Baseline Visit): Omega-3 supplementation, tetrabenazine or reserpine, high dose and/or variable dose oral anti-psychotic medications, steroid (other than topical), selenium supplements greater than 55 mcg/day, lithium, benzodiazepines (except for low dose), anticoagulants
结局指标
主要结局
To compare with placebo the effect of ethyl-EPA on the Total Motor Score-4 component (TMS) of the Unified Huntington's Disease Rating Scale (UHDRS) over a 6-month period of observation.
次要结局
- To compare with placebo the effect of ethyl-EPA over a 6-month period of observation on, 1) Chorea (UHDRS Total Motor Score Scale); 2) Total Motor Score component (TMS) of the UHDRS; and, 3) Clinical Global Impression (CGI) score.
研究者
研究点 (42)
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