A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 4
- 主要终点
- The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness.
研究概览
简要总结
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
详细描述
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects who have a diagnosis of PD based on UK brain bank criteria with ESS> 7 will be received Selegiline as an adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and greater from 30 to
- •Diagnosis of idiopathic PD according to the UK Brain Bank criteria.
- •Epworth Sleepiness Scale (ESS) >
- •Stable dose of anti-Parkinson drugs for at least 30 days.
- •No use of MAO-B inhibitors within the preceding 4 weeks.
- •No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.
排除标准
- •Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
- •Shift-work, which cannot ensure a stable sleep-wake cycle habits.
- •History of contraindications.
研究组 & 干预措施
Selegiline
Subjects who meet all of the inclusion and none of the exclusion criteria will be received Selegiline.The study medication dosage will be escalated from 5mg/daily to the target dose(5~10mg/daily) in 2 weeks and then maintained for the remaining 6 weeks.
干预措施: Selegiline (Drug)
结局指标
主要结局
The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness.
时间窗: 8 weeks
This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.
次要结局
- The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.(8 weeks)
- The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.(8 weeks)
- The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.(8 weeks)