NCT01923584已完成2 期
A Phase 2A Trial of EPI-743 for Patients With Parkinson'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
- 15
- 试验地点
- 1
- 主要终点
- Visual function
研究概览
简要总结
The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Age 40 - 75
- •Ambulatory with or without assistance
- •Hoehn and Yahr Scale score of 1 - 3
- •Patient able to consent and comply with protocol requirements
- •Abstention from use of Coenzyme Q10, vitamin E, Azilect and Idebenone two weeks prior to enrollment and during course of treatment with EPI-743
排除标准
- •Allergy to EPI-743 or sesame oil
- •Allergy to vitamin E
- •Clinical history of bleeding or abnormal baseline PT/PTT
- •Diagnosis of any other neurologic disease
- •Malignancy within past two years
- •Pregnant or plans to become pregnant
- •Concomitant ophthalmologic disease
- •History of stroke
- •History of brain surgery
- •Inability to undergo MRI scan or MRS
- •Hepatic insufficiency with LFTs greater than two times upper limit of normal
- •Renal insufficiency requiring dialysis
- •End stage cardiac failure
- •Fat malabsorption syndromes precluding drug absorption
- •Use of anticoagulant medications, azilect
研究组 & 干预措施
EPI-743 400mg
Active Comparator
EPI-743 at a dose of 400 mg three times daily
干预措施: EPI-743 400mg (Drug)
EPI-743 200mg
Active Comparator
EPI-743 at a dose of 200 mg three times daily
干预措施: EPI-743 200mg (Drug)
结局指标
主要结局
Visual function
时间窗: 3 months
electroretinogram and color vision
次要结局
- Cognitive function(3 months)
- Mood(3 months)
- Disease biomarkers(3 months)
- Neurologic function(3 months)
- Motor function(3 months)
- Brain metabolites(3 months)
- Safety(3 months)
研究者
研究点 (1)
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