NCT02473562

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2013

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4.7 years

First QC Date

June 12, 2015

Last Update Submit

October 4, 2018

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseVareniclineExcessive daytime sleepiness

Outcome Measures

Primary Outcomes (1)

  • Daytime sleepiness

    Epworth Sleepiness Scale

    4 weeks

Secondary Outcomes (7)

  • Sleep quality

    4 weeks

  • Fatigue

    4 weeks

  • Involuntary movements

    4 weeks

  • Quality of life

    4 weeks

  • Sleep latency

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Varenicline

EXPERIMENTAL

Varenicline capsule 1 mg BID

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo (for varenicline)

Interventions

VareniclineDRUG

Tablet 1 mg BID

Also known as: Champix
Varenicline
Placebo (for varenicline)DRUG

Tablet 1 mg BID

Also known as: Placebo
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Academic Medical Center

Amsterdam, 1100 DD, Netherlands

Location

VU university medical center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Parkinson DiseaseDisorders of Excessive Somnolence

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Elisabeth Foncke, PhD, MD

    VU University Medical Center, depart. of neurology

    STUDY CHAIR

  • Bernard Uitdehaag, Phd, MD

    VU University Medical Center, depart. of neurology

    PRINCIPAL INVESTIGATOR

  • Tom van Mierlo, MD

    VU University Medical Center, depart. of neurology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

May 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

NL(2)