NCT00599339已完成不适用
A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 2,195
- 试验地点
- 211
- 主要终点
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
研究概览
简要总结
This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.
详细描述
All patients attending the physician and fulfilling the eligibility criteria are included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset
- •Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset
排除标准
- •Patients who are unable to comply with study requirements
结局指标
主要结局
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
时间窗: From Baseline to Visit 7 (Month 33)
The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).
次要结局
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)(From Baseline to Visit 7 (Month 33))
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)(From Baseline to Visit 7 (Month 33))
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)(33 months)
- Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)(33 months)
- Hoehn & Yahr Stage at Visit 7 (Month 33)(33 months)
- Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)(33 months)
研究者
研究点 (211)
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