NCT00199368已完成3 期
A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
详细描述
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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-EU-007, 6002-US-013 or 6002-US-018
- •Non-pregnant and either not of childbearing potential or using specified contraception
排除标准
- •History of psychotic illness
- •Variant/atypical Parkinson's disease
- •Cancer within 5 years of enrollment
- •ALT/AST levels > 1.5 times ULN
- •Seizure disorder
- •Neuroleptic malignant syndrome
结局指标
主要结局
Safety
次要结局
- Safety
研究者
研究点 (2)
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