Varenicline, a partial nicotinic receptor agonist for the treatment of Excessive Daytime Sleepiness in Parkinson’s Disease: a placebo-controlled cross-over study - Vareniciline for Excessive daytime Sleepiness in PArkinson’s disease (VESPA)

VU University Medical Center0 个研究点目标入组 32 人开始时间: 2012年8月9日最近更新: 2018年3月26日

适应症

试验速览

暂无简介。

•- idiopathic PD according to clinical diagnostic criteria UK PD Society Brain Bank
•- receiving stable PD medications for at least four weeks before and throughout study
•- suffering EDS, defined by a score of >10 on the Epworth Sleeping Scale (ESS)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•- PD patients receiving medications with known central depressant effects (benzodiazepines, neuroleptics, anticholinergics)
•- dementia defined by a Mini Mental State Examination (MMSE) <24
•- depression defined by a Beck Depression Inventory (BDI) >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, 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

发起方

VU University Medical Center