The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,464
- 主要终点
- Occurrence of tremor (rest and postural) by means of a 4-point rating scale
研究概览
简要总结
Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability 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 with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study
排除标准
- •Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®
- •Patients under treatment with neuroleptics should not be observed during this study
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
Occurrence of tremor (rest and postural) by means of a 4-point rating scale
时间窗: up to 6 weeks
Short Parkinson's Evaluation Scale (SPES)
Change in severity of kinetic tremor assessed by tremor spiral test
时间窗: up to 6 weeks
Occurrence of depression by means of a 4-point SPES rating scale
时间窗: up to 6 weeks
Change in Parkinson signs and symptoms by means of a 4-point rating scale
时间窗: up to 6 weeks
Assessment of efficacy by investigator on a 5-point rating scale
时间窗: after 6 weeks
Change in severity of depression by means of an 8-point rating scale
时间窗: up to 6 weeks
Clinical Global Impression (CGI) rating scale
Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)
时间窗: up to 6 weeks
VAS (10 cm)
次要结局
- Number of patients with adverse drug reactions(up to 6 weeks)
- Assessment of tolerability by investigator on a 5-point scale(after 6 weeks)
- Assessment of tolerability by patient on a 5-point scale(after 6 weeks)