NCT02248220已完成不适用
Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 主要终点
- Change in cumulative daily doses of Sifrol®
研究概览
简要总结
Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability
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 advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated
排除标准
- 未提供
研究组 & 干预措施
Parkinson's disease patients
干预措施: Pramipexole (Drug)
结局指标
主要结局
Change in cumulative daily doses of Sifrol®
时间窗: up to 8 weeks
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
Changes in cumulative daily doses of L-dopa
时间窗: up to 8 weeks
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
次要结局
- Global assessment of efficacy by investigator on a 5-point scale(after 8 weeks)
- Number of patients with adverse drug reactions(up to 8 weeks)
- Change from Baseline in SPES subscales(Baseline, after 8 weeks)
- Change from Baseline in global Parkinson's Disease (PD) symptoms(Baseline, after 8 weeks)
- Global assessment of tolerability by investigator on a 5-point scale(after 8 weeks)
- Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score(Baseline, after 8 weeks)
- Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score(Baseline, after 8 weeks)
- Number of patients with adverse events(up to 8 weeks)
- Change from Baseline in Tremor Impact Scale (TIS-D) total score(Baseline, after 8 weeks)
研究者
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