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 qualityFatigue 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
|