Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,216
- 主要终点
- Reason for switch of therapy and reason for using Sifrol®
研究概览
简要总结
Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions
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 Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®
排除标准
- •Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
研究组 & 干预措施
Idiopathic Parkinson's disease patients
干预措施: Sifrol® (Drug)
结局指标
主要结局
Reason for switch of therapy and reason for using Sifrol®
时间窗: up to 8 weeks
questionnaire
Type of switch (abrupt or overlapping)
时间窗: up to 8 weeks
Changes in motor function by means of 5-points rating scale
时间窗: up to 8 weeks
Short Parkinson's Evaluation Scale (SPES)
Changes in psychopathological memory disturbances by means of 5- point rating scale
时间窗: up to 8 weeks
Short Parkinson's Evaluation Scale (SPES)
Changes in psychopathological thought disorder disturbances by means of 5- point rating scale
时间窗: up to 8 weeks
SPES score
Changes in psychopathological depression disturbances by means of 5- point rating scale
时间窗: up to 8 weeks
SPES score
Changes of mood on seven visual analogue scales (VASs)
时间窗: up to 8 weeks
assessed by patient
Equivalent doses of Sifrol®
时间窗: after 8 weeks
compared to previous treatment dosing, based on global clinical impression
Global assessment of efficacy by investigator on a 5-point rating scale
时间窗: after 8 weeks
次要结局
- Number of patients with adverse drug reactions(up to 8 weeks)
- Assessment of tolerability by investigator on a 5-point rating scale(after 8 weeks)