A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 84
- 主要终点
- Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
研究概览
简要总结
The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of trial SP889
排除标准
- •Ongoing serious adverse event assessed as related to trial medication
研究组 & 干预措施
Rotigotine
Rotigotine Transdermal Patch
干预措施: Rotigotine (Drug)
结局指标
主要结局
Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
时间窗: Baseline (baseline SP915) and week 13 (End of maintenance)
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915.
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
时间窗: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889.
次要结局
- Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)(Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance))
- Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)(Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance))