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Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

Information source: VU University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: Varenicline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: VU University Medical Center

Overall contact:
Tom van Mierlo, MD, Phone: 0031204440708, Email: t.vanmierlo@vumc.nl

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Daytime sleepiness

Secondary outcome:

Sleep quality

Fatigue

Involuntary movements

Quality of life

Sleep latency

Pharmacodynamics assessed by computerized test battery

Error score

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Tom van Mierlo, MD, Phone: 0031204440708, Email: t.vanmierlo@vumc.nl

Academic Medical Center, Amsterdam 1100 DD, Netherlands; Recruiting
Rob de Bie, dr, Phone: 003120-5663415, Email: r.m.debie@amc.uva.nl
Rob de Bie, Dr, Principal Investigator

VU university medical center, Amsterdam, Netherlands; Recruiting
Tom van Mierlo, MD, Phone: 0031204440708, Email: t.vanmierlo@vumc.nl

Additional Information

Starting date: May 2013
Last updated: June 15, 2015

Page last updated: August 23, 2015

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