A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
研究概览
简要总结
Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the quality of life of affected patients.
Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase type-B (MAO-B) inhibitor with a 24h dopaminergic effect.
It is well known that dopaminergic treatment closely interacts with SWD. This study aims to assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind, placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline 1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan scale) and QoL in PD patients.
- Trial with medicinal product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 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
研究组 & 干预措施
Placebo
干预措施: Rasagiline (Drug)
Rasagiline
干预措施: Rasagiline (Drug)
结局指标
主要结局
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
时间窗: Baseline after 8 weeks of treatment
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
次要结局
未报告次要终点