NCT01063621已完成3 期
Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)
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
- 27
- 主要终点
- Adverse events and related adverse events
研究概览
简要总结
This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.
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
- •Patients who have given written informed consent
- •Patients who have completed the 6500-004 study
排除标准
- 未提供
研究组 & 干预措施
KW-6500
Experimental
干预措施: KW-6500 (Drug)
结局指标
主要结局
Adverse events and related adverse events
时间窗: From first administration of study drug through Study Week 52
次要结局
- Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score(From first administration of study drug through Study Week 52)
研究者
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