An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 395
- 主要终点
- Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
研究概览
简要总结
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease
详细描述
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on 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
- 31 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial
排除标准
- •Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication
研究组 & 干预措施
Rotigotine
Rotigotine
干预措施: Rotigotine (Drug)
结局指标
主要结局
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
时间窗: five years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
次要结局
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event(five years)
- Mean Epworth Sleepiness Scale Score During the Open-label Extension(Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4))