NCT00599196已完成3 期
An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic 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
- 发起方
- UCB Pharma
- 入组人数
- 381
- 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 early-stage idiopathic Parkinson's disease
详细描述
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease
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
- •Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial
排除标准
- •Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
研究组 & 干预措施
Rotigotine
Experimental
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: six 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
- Mean Epworth Sleepiness Scale Score During the Open-label Extension(Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit))
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event(six years)
研究者
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