Vareniciline treatment for Excessive Daytime Sleepiness in Parkinson’s Disease

Phase 1

Conditions: Idiopathic Parkinson's disease
MedDRA version: 18.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-001530-34-NL

Lead Sponsor: VU University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: primary objective is determining the efficacy of varenicline in reducing EDS in PD patients after 4 weeks of daily use. ;Secondary Objective: As secondary objectives we investigate whether varenicline treatment improves nocturnal sleep quality and quality of life.;Primary end point(s): the difference in severity of EDS as measured by the ESS at baseline and after four weeks treatment (varenicline vs placebo) ;Timepoint(s) of evaluation of this end point: after two times four weeks treatment (cross over design)

Secondary Outcome Measures