Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborator: Centre for Human Drug Research, Netherlands
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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