BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,089
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
研究概览
简要总结
The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.
i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
时间窗: for 12 weeks
The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.
次要结局
- Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score(Baseline and after 12 weeks (or at the time of discontinuation))
- Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale(After 12 weeks or at the time of discontinuation)
- Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score(Baseline and after 12 weeks (or at the time of discontinuation))
- Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score(Baseline and after 12 weeks (or at the time of discontinuation))
- Clinical Global Impression of Improvement(for 12 weeks after initiation of the treatment)