Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,703
- 试验地点
- 215
- 主要终点
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
研究概览
简要总结
The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.
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
- •Idiopathic Parkinson's disease with or without fluctuations
- •Indication for treatment with pramipexole (Mirapexin®)
- •Presence of at least mild tremor symptoms (as judged by the treating physician)
排除标准
- •Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- •Ongoing treatment with pramipexole (Mirapexin®)
结局指标
主要结局
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
时间窗: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
时间窗: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in tremor amplitude from baseline to end of study for the left hand
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
时间窗: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
时间窗: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in tremor amplitude from baseline to end of study for the right hand
Change From Baseline in UPDRS Part III Score at the End of Maintenance
时间窗: Week 0 to weeks 9-16
Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
时间窗: Week 0 to weeks 9-16 (Visit 3)
Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
次要结局
- Change From Baseline in UPDRS Part III Score at the End of Up-titration(Enter Week 0 to weeks 1-8 (Visit 2))
- Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration(Enter Week 0 to weeks 1-8 (Visit 2))
- Final Dose Distribution(Enter Week 0 to weeks 9-16 (Visit 3))
- Change From Baseline in UPDRS Part II Score at the End of Up-titration(Enter Week 0 to weeks 1-8 (Visit 2))
- Number of Premature Discontinuations(Week 0 to weeks 9-16 (end of study))
- Incidence, Relationship and Seriousness of Adverse Events(Week 0 to weeks 9-16 (end of study))