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
干预措施
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
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Transdermal Patches
干预措施: Placebo (Other)
Rotigotine
Experimental
Rotigotine Transdermal Patches
干预措施: Rotigotine (Other)
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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