Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

Parkinson's Disease Clinical Trial

— VESPA  

Official title:

Varenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02473562
• Other study ID #: NL40128.029.12
• Status: Terminated
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: January 2018

Study information

• Verified date: October 2018
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Varenicline
Tablet 1 mg BID
• Placebo (for varenicline)
Tablet 1 mg BID

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	VU university medical center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	Centre for Human Drug Research, Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime sleepiness	Epworth Sleepiness Scale	4 weeks
Secondary	Sleep quality	Pittsburgh Sleep Quality Index	4 weeks
Secondary	Fatigue	Fatigue Severity Scale	4 weeks
Secondary	Involuntary movements	Abnormal Involuntary Movements Scale	4 weeks
Secondary	Quality of life	Medical Outcomes Study 36-Item Short-Form Health Survey	4 weeks
Secondary	Sleep latency	Maintenance of Wakefulness Test	4 weeks
Secondary	Pharmacodynamics assessed by computerized test battery		4 weeks
Secondary	Error score	Sustained Attention to Response Test	4 weeks