NCT00505687已完成3 期
A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With 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
- 186
- 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 rotigotine in subjects with idiopathic PD.
详细描述
This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with 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
- 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 treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials
排除标准
- •Subjects who had an ongoing serious adverse event from the previous OLE 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: four 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 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit))
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event(four years)
研究者
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