A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
研究概览
简要总结
To establish the efficacy of a 20 mg/day dose 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 a 20 mg/d dose 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 to 1 ratio to either 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 as compared to placebo.
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/carbidopa for at least one year, stable dose in past 4 weeks.
- •Currently take at least three doses of levodopa/carbidopa per day.
- •Predictable end of dose wearing off.
- •Able to satisfactorily complete Hauser version of a Parkinson's diary.
- •Have an average of 180 minutes of OFF time on two 24 hour diaries.
- •Be at least 30 years of age.
排除标准
- •Neurosurgical treatment for PD.
- •History of psychosis.
- •Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
- •Diagnosis of cancer within 5 years.
- •Mini-mental status examination score of 25 or less.
- •History of seizures or neurologic malignant_syndrome.
- •Clinical depression.
结局指标
主要结局
To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
次要结局
- 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 Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
- To evaluate the change in the Patient Global Impression - Improvement scale (PGI-I).
- To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
- To evaluate the safety of a 20 mg/d dose of istradefylline.
- To evaluate the efficacy of a 20 mg/d dose of istradefylline for reducing the total hours of OFF time.
- To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).