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Clinical Trials/NCT02452606
NCT02452606UnknownNot Applicable

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

Asan Medical Center1 site in 1 country100 target enrollmentStarted: March 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
The correlation of the genetic variants of central circadian clock and narcolepsy genes with regard to the treatment effect of Stalevo® in sleep disturbance of parkinson's disease.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients diagnosed with PD in accordance with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (Hughes AJ, et al. 1992).
  • •Patients with PD who have wearing off phenomenon.
  • •Patients with PD with Hoehn and Yahr stage 1-
  • •Patients with PD who have sleep problems (PDSS score ≤120 or Epworth Sleepiness Scale(ESS) score ≥ 8).
  • •Patients with PD who showed Montreal Cognitive Assessment (MoCA) score ≥
  • •Patients with PD who have no major depression (Geriatric depression scale, GDS ≤ 24)

Exclusion Criteria

  • •Secondary parkinsonism
  • •Parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration.
  • •Patients with PD who have history of severe side effect of Stalevo®.

Arms & Interventions

Stalevo®

Experimental

Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month.

Intervention: Stalevo® (Drug)

Outcomes

Primary Outcomes

The correlation of the genetic variants of central circadian clock and narcolepsy genes with regard to the treatment effect of Stalevo® in sleep disturbance of parkinson's disease.

Time Frame: 2 years

To determine whether the genetic variants of clock and narcolepsy genes are associated with the effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation.

Secondary Outcomes

  • The effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation (using Parkinson's Disease Sleep Scale)(up to 3 months from enrollment.)
  • The effectiveness about improving the EDS(Excessive daytime sleepiness) in PD patients with motor fluctuation after taking Stalevo® in bedtime.(up to 3 months from enrollment.)
  • The effectiveness about improving the morning motor symptoms in PD patients with motor fluctuation after taking Stalevo® in bedtime.(up to 3 months from enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sun Ju Chung

Professor

Asan Medical Center

Study Sites (1)

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