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Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease (VESPA)

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ClinicalTrials.gov Identifier: NCT02473562
Recruitment Status : Terminated (insufficient patient enrollment, insufficient funds for completion)
First Posted : June 16, 2015
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Centre for Human Drug Research, Netherlands
Information provided by (Responsible Party):
Tom van Mierlo, VU University Medical Center

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Varenicline Drug: Placebo (for varenicline) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Varenicline
Varenicline capsule 1 mg BID
Drug: Varenicline
Tablet 1 mg BID
Other Name: Champix

Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo (for varenicline)
Tablet 1 mg BID
Other Name: Placebo




Primary Outcome Measures :
  1. Daytime sleepiness [ Time Frame: 4 weeks ]
    Epworth Sleepiness Scale


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 4 weeks ]
    Pittsburgh Sleep Quality Index

  2. Fatigue [ Time Frame: 4 weeks ]
    Fatigue Severity Scale

  3. Involuntary movements [ Time Frame: 4 weeks ]
    Abnormal Involuntary Movements Scale

  4. Quality of life [ Time Frame: 4 weeks ]
    Medical Outcomes Study 36-Item Short-Form Health Survey

  5. Sleep latency [ Time Frame: 4 weeks ]
    Maintenance of Wakefulness Test

  6. Pharmacodynamics assessed by computerized test battery [ Time Frame: 4 weeks ]
  7. Error score [ Time Frame: 4 weeks ]
    Sustained Attention to Response Test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473562


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1100 DD
VU university medical center
Amsterdam, Netherlands
Sponsors and Collaborators
VU University Medical Center
Centre for Human Drug Research, Netherlands
Investigators
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Study Chair: Elisabeth Foncke, PhD, MD VU University Medical Center, depart. of neurology
Principal Investigator: Bernard Uitdehaag, Phd, MD VU University Medical Center, depart. of neurology
Study Director: Tom van Mierlo, MD VU University Medical Center, depart. of neurology

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Responsible Party: Tom van Mierlo, MD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02473562     History of Changes
Other Study ID Numbers: NL40128.029.12
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Keywords provided by Tom van Mierlo, VU University Medical Center:
Parkinson's disease
Varenicline
Excessive daytime sleepiness

Additional relevant MeSH terms:
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Varenicline
Parkinson Disease
Sleepiness
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs