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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02473562 |
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Date of registration:
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12/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease
VESPA |
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Scientific title:
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Varenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot Study |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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22 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02473562 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Tom van Mierlo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VU University Medical Center, depart. of neurology |
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Name:
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Bernard Uitdehaag, Phd, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VU University Medical Center, depart. of neurology |
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Name:
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Elisabeth Foncke, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VU University Medical Center, depart. of neurology |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo (for varenicline)
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Drug: Varenicline
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Primary Outcome(s)
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Daytime sleepiness
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Pharmacodynamics assessed by computerized test battery
[Time Frame: 4 weeks]
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Fatigue
[Time Frame: 4 weeks]
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Error score
[Time Frame: 4 weeks]
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Involuntary movements
[Time Frame: 4 weeks]
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Sleep quality
[Time Frame: 4 weeks]
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Quality of life
[Time Frame: 4 weeks]
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Sleep latency
[Time Frame: 4 weeks]
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Secondary ID(s)
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NL40128.029.12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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