Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

NCT ID: NCT02473562

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-01-31

Brief 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.

Detailed Description

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Varenicline

Varenicline capsule 1 mg BID

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Tablet 1 mg BID

Placebo

Placebo capsule

Group Type: PLACEBO_COMPARATOR

Placebo (for varenicline)

Intervention Type: DRUG

Tablet 1 mg BID

Interventions

Varenicline

Tablet 1 mg BID

Intervention Type: DRUG

Placebo (for varenicline)

Tablet 1 mg BID

Intervention Type: DRUG

Other Intervention Names

Champix; Placebo

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Human Drug Research, Netherlands

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Tom van Mierlo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth Foncke, PhD, MD

Role: STUDY_CHAIR

VU University Medical Center, depart. of neurology

Bernard Uitdehaag, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

VU University Medical Center, depart. of neurology

Tom van Mierlo, MD

Role: STUDY_DIRECTOR

VU University Medical Center, depart. of neurology

Locations

Academic Medical Center

Amsterdam, , Netherlands

VU university medical center

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL40128.029.12

Identifier Type: -

Identifier Source: org_study_id