Parkinson's DiseasePhase 4VESPANCT02473562
Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease
A Phase 4 study testing Varenicline in people with Parkinson's Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2013to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic Medical Center
Amsterdam, 1100 DD
VU university medical center
Amsterdam
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Varenicline, Placebo (for varenicline)
- Keywords
- Parkinson's disease, Varenicline, Excessive daytime sleepiness
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix
Tablet 1 mg BID
Placebo (for varenicline)Drug
Also called Placebo
Tablet 1 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Varenicline capsule 1 mg BID Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo (for varenicline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime sleepiness
Epworth Sleepiness Scale
Measured: 4 weeks
Secondary outcomes (7)
Sleep quality
Pittsburgh Sleep Quality Index
Measured: 4 weeks
Fatigue
Fatigue Severity Scale
Measured: 4 weeks
Involuntary movements
Abnormal Involuntary Movements Scale
Measured: 4 weeks
Quality of life
Medical Outcomes Study 36-Item Short-Form Health Survey
Measured: 4 weeks
Sleep latency
Maintenance of Wakefulness Test
Measured: 4 weeks
Pharmacodynamics assessed by computerized test battery
Measured: 4 weeks
Error score
Sustained Attention to Response Test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startMay 2013
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: insufficient patient enrollment, insufficient funds for completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Human Drug Research, Netherlands
- Responsible party
- Principal investigator, Tom van Mierlo, Amsterdam UMC, location VUmc
- Investigators
- Elisabeth Foncke, PhD, MD, Study chair, VU University Medical Center, depart. of neurologyBernard Uitdehaag, Phd, MD, Principal investigator, VU University Medical Center, depart. of neurologyTom van Mierlo, MD, Study director, VU University Medical Center, depart. of neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473562
- Sponsor's protocol ID
- NL40128.029.12
- Acronym
- VESPA
- Status last verified
- Oct 2018
- First submitted
- 12 Jun 2015
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02473562
- Acronym / sponsor ID
- VESPA / NL40128.029.12
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Varenicline, Excessive daytime sleepiness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient enrollment, insufficient funds for completion
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Centre for Human Drug Research, Netherlands
- Study start
- May 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineVarenicline capsule 1 mg BID |
| Placebo | Placebo comparator | Drug: Placebo (for varenicline)Placebo capsule |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChampixTablet 1 mg BID | Drug | Varenicline |
| Placebo (for varenicline)Also: PlaceboTablet 1 mg BID | Drug | Placebo |
Primary outcome
Daytime sleepiness
Time frame: 4 weeks
Epworth Sleepiness Scale
7 secondary outcomes
Sleep quality
Time frame: 4 weeks
Fatigue
Time frame: 4 weeks
Involuntary movements
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
Sleep latency
Time frame: 4 weeks
Pharmacodynamics assessed by computerized test battery
Time frame: 4 weeks
Error score
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: insufficient patient enrollment, insufficient funds for completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Foncke, PhD, MD study chair
VU University Medical Center, depart. of neurology
Bernard Uitdehaag, Phd, MD principal investigator
VU University Medical Center, depart. of neurology
Tom van Mierlo, MD study director
VU University Medical Center, depart. of neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Parkinson's Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient patient enrollment, insufficient funds for completion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime sleepiness (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.