Varenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Daytime sleepiness
研究概览
简要总结
The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind, placebo-controlled clinical trial with a within-subject crossover design.
详细描述
Sleep disturbances are common in Parkinson's disease and include excessive daytime sleepiness that has been reported in up to 50% of patients. Relatively little therapeutic research has addressed the problem of excessive daytime sleepiness and current treatment is largely aimed at reducing the dose of dopaminergic medication while trying to maintain sufficient motor control which unfortunately often fails. Apart from degeneration of dopaminergic neurons, a decrease in cholinergic projections to the brain arousal areas may be at least partly responsible for the occurrence of excessive daytime sleepiness in Parkinson's disease. Smoking in narcoleptic patients diminishes sleep attacks and excessive daytime sleepiness , thus one may hypothesize that nicotinergic stimulation of the brain arousal areas may improve excessive daytime sleepiness in Parkinson's disease. Therefore the effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist, on excessive daytime sleepiness in Parkinson's disease will be studied in a placebo-controlled cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic Parkinson's Disease according to clinical diagnostic criteria United Kingdom Parkinson's Disease Society Brain Bank
- •receiving stable Parkinson's medications for at least four weeks before and throughout study
- •suffering Excessive Daytime Sleepiness, defined by a score of >10 on the Epworth Sleeping Scale
- •written informed consent
排除标准
- •Parkinson's Disease patients receiving medications with known central depressant effects (benzodiazepines, neuroleptics, anticholinergics)
- •dementia defined by a Mini Mental State Examination <24
- •depression defined by a Beck Depression Inventory >16
- •a known diagnosis of sleep apnea or narcolepsy
- •current smoking or smoking cessation in past 6 months
- •presence of contra-indications for treatment with varenicline, including:
- •known psychiatric diseases such as panic disorder, psychosis, bipolar disorder, eating disorder and alcohol or drug abuse
- •unstable angina, a history of cardiac disease or stroke in previous 6 months
- •severe renal failure (glomerular filtration rate ≤ 30 ml/min)
- •insulin-dependent diabetes
研究组 & 干预措施
Varenicline
Varenicline capsule 1 mg BID
干预措施: Varenicline (Drug)
Placebo
Placebo capsule
干预措施: Placebo (for varenicline) (Drug)
结局指标
主要结局
Daytime sleepiness
时间窗: 4 weeks
Epworth Sleepiness Scale
次要结局
- Sleep quality(4 weeks)
- Fatigue(4 weeks)
- Involuntary movements(4 weeks)
- Quality of life(4 weeks)
- Sleep latency(4 weeks)
- Pharmacodynamics assessed by computerized test battery(4 weeks)
- Error score(4 weeks)
研究者
Tom van Mierlo
MD
Amsterdam UMC, location VUmc