Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.
研究概览
简要总结
To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
详细描述
To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
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
- •UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
- •PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
- •On levodopa/DCI for at least one year, stable dose in past 4 weeks.
- •Currently take at least three doses of levodopa/DCI per day.
- •Predictable end of dose wearing off.
- •Able to satisfactorily complete Hauser version of a Parkinson's diary.
- •Have an average of 120 minutes of OFF time on two 24 hour diaries.
- •On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
- •Be at least 30 years of age.
排除标准
- •Neurosurgical treatment for PD.
- •History of psychosis.
- •Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
- •Diagnosis of cancer within 5 years.
- •Diagnosis of clinically significant illness of any organ system.
- •Mini-mental status examination score of 25 or less.
- •Taking any excluded medications.
- •History of drug or alcohol abuse or dependence within the past two years.
- •History of seizures or neurological malignant syndrome.
- •Clinical depression.
- •Pregnant or lactating females.
结局指标
主要结局
To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.
次要结局
- To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
- To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
- To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
- To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.
- To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
- To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).