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

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Varenicline
Placebo (for varenicline)
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Varenicline, Excessive daytime sleepiness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center
  • VU university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Varenicline

Placebo

Arm Description

Varenicline capsule 1 mg BID

Placebo capsule

Outcomes

Primary Outcome Measures

Daytime sleepiness
Epworth Sleepiness Scale

Secondary Outcome Measures

Sleep quality
Pittsburgh Sleep Quality Index
Fatigue
Fatigue Severity Scale
Involuntary movements
Abnormal Involuntary Movements Scale
Quality of life
Medical Outcomes Study 36-Item Short-Form Health Survey
Sleep latency
Maintenance of Wakefulness Test
Pharmacodynamics assessed by computerized test battery
Error score
Sustained Attention to Response Test

Full Information

First Posted
June 12, 2015
Last Updated
October 4, 2018
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Centre for Human Drug Research, Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT02473562
Brief Title
Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
insufficient patient enrollment, insufficient funds for completion
Study Start Date
May 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Centre for Human Drug Research, Netherlands

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Varenicline, Excessive daytime sleepiness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Experimental
Arm Description
Varenicline capsule 1 mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Champix
Intervention Description
Tablet 1 mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo (for varenicline)
Other Intervention Name(s)
Placebo
Intervention Description
Tablet 1 mg BID
Primary Outcome Measure Information:
Title
Daytime sleepiness
Description
Epworth Sleepiness Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index
Time Frame
4 weeks
Title
Fatigue
Description
Fatigue Severity Scale
Time Frame
4 weeks
Title
Involuntary movements
Description
Abnormal Involuntary Movements Scale
Time Frame
4 weeks
Title
Quality of life
Description
Medical Outcomes Study 36-Item Short-Form Health Survey
Time Frame
4 weeks
Title
Sleep latency
Description
Maintenance of Wakefulness Test
Time Frame
4 weeks
Title
Pharmacodynamics assessed by computerized test battery
Time Frame
4 weeks
Title
Error score
Description
Sustained Attention to Response Test
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Foncke, PhD, MD
Organizational Affiliation
VU University Medical Center, depart. of neurology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernard Uitdehaag, Phd, MD
Organizational Affiliation
VU University Medical Center, depart. of neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom van Mierlo, MD
Organizational Affiliation
VU University Medical Center, depart. of neurology
Official's Role
Study Director
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
VU university medical center
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

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Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

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