NCT00456586已完成2 期
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
研究概览
简要总结
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
详细描述
A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
- •Modified Hoehn and Yahr Scale II-IV in the OFF state.
- •Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
- •Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
- •Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
- •Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
- •At least 30 years of age and able to give written informed consent.
排除标准
- •Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
- •Treatment with MAO inhibitors except selegiline.
- •Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- •Neurosurgical surgery for Parkinson's disease.
- •Atypical parkinsonism or secondary parkinsonism variants.
- •Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
- •Mini-Mental Status Examination score of 25 or less.
- •History of drug or alcohol abuse or dependence within 2 years.
- •History of psychotic illness or seizures.
- •Current clinically relevant depression disorder.
- •History of neuroleptic malignant syndrome.
- •Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.
结局指标
主要结局
To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
次要结局
- To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.
研究者
研究点 (2)
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