Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).
研究概览
简要总结
To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).
详细描述
To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated 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
- Crossover
- 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 1-3 for Modified Hoehn and Yahr Scale.
- •Be at least 30 years of age.
排除标准
- •Neurosurgical treatment for PD.
- •History of psychosis.
- •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 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).
次要结局
- To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.
- To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
- To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
- To evaluate the safety of 40mg/d doses of istradefylline.