NCT00199381终止3 期
An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Safety as Measured by Adverse Events
研究概览
简要总结
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
详细描述
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of study 6002-INT-001
- •Not of childbearing potential
排除标准
- •Cancer within 5 years of enrollment
- •ALT/AST levels > 2.5 times ULN
研究组 & 干预措施
Single Arm
Experimental
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
干预措施: Istradefylline (Drug)
结局指标
主要结局
Safety as Measured by Adverse Events
时间窗: Every 2 months up to 32 months
Investigation of the long-term tolerability and safety of istradefylline
次要结局
未报告次要终点
研究者
研究点 (1)
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