NCT01519882终止4 期
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period
研究概览
简要总结
This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced Parkinson's disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))
- •Hoehn and Yahr stage score of 2 to 4
- •Subject has sleep-maintenance insomnia
排除标准
- •Significant skin disease that would make transdermal drug use inappropriate
- •Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone
- •Atypical Parkinsonian syndromes
- •Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder
结局指标
主要结局
Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period
时间窗: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between "lights off" and "lights on").
次要结局
- Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period(From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline))
- Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
- Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period(From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline))
- Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
- Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
- Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period(From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline))
- Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
- Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
- Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
研究者
研究点 (1)
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