NCT00957203已完成3 期
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 308
- 主要终点
- Adverse events
研究概览
简要总结
Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to give written informed consent
- •Completion of the study 6002-009
排除标准
- •Mini-mental status examination score of 23 or less
- •Less than 70% of compliance in the study 6002-009
- •Emergency deviation in the study 6002-009
- •Pregnant females
研究组 & 干预措施
Istradefylline
Experimental
干预措施: Istradefylline (Drug)
结局指标
主要结局
Adverse events
次要结局
- Change in the Clinical Global Impression - Improvement scale (CGI-I)
- Reducing the mean total hours of awake time per day spent in the OFF state
- Reducing the mean percentage of awake time per day spent in the OFF state
- Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS)
研究者
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