NCT00594165已完成3 期
An Open-Label Extension to the Double-Blind SP512 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
- 217
- 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-controlled SP512 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
- 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 six months of maintenance treatment in the SP512 double-blind trial
排除标准
- •Subjects who had an ongoing serious adverse event from SP512 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: 7 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.(7 years)
- Mean Epworth Sleepiness Scale Score During the Open-label Extension.(Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit))
研究者
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