NCT00456794已完成2 期
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 2
- 主要终点
- Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.
研究概览
简要总结
A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease 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 (Steps 1 and 2).
- •Modified Hoehn and Yahr in the OFF state of II-IV.
- •Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
- •Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formulation) with predictable end of dose wearing off.
- •Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
- •Stable regimen of other antiparkinson's medications for 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/carbidopa within 4 weeks of randomization.
- •Treatment with MAO inhibitors except selegiline.
- •Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formulations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- •Neurosurgical operation for Parkinson's disease.
- •Atypical parkinsonism or secondary parkinsonism variants.
- •Diagnosis of cancer or evidence of continued disease within 5 years.
- •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.
- •Clinically relevant depression disorder.
- •History of neuroleptic malignant syndrome.
- •Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
结局指标
主要结局
Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.
次要结局
- Actual values and mean change from Baseline in percentage and total hours of awake time per day in the OFF state and ON state, UPDRS I-IV, II and III Scores during ON and OFF states, Global Clinical Impression-Improvement (CGI-I), safety
研究者
研究点 (2)
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