Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
NCT ID: NCT02452606
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-03-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stalevo®
Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month.
Stalevo®
* Sleep disorders in Parkinson's disease
* Analysis by Parkinson's Disease Sleep Scale(PDSS) scores.
* If the PDSS score is improving at least 15 percent than the baseline score, It can be determined to be effective.
Interventions
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Stalevo®
* Sleep disorders in Parkinson's disease
* Analysis by Parkinson's Disease Sleep Scale(PDSS) scores.
* If the PDSS score is improving at least 15 percent than the baseline score, It can be determined to be effective.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with PD who have wearing off phenomenon.
3. Patients with PD with Hoehn and Yahr stage 1-4.
4. Patients with PD who have sleep problems (PDSS score ≤120 or Epworth Sleepiness Scale(ESS) score ≥ 8).
5. Patients with PD who showed Montreal Cognitive Assessment (MoCA) score ≥15.
6. Patients with PD who have no major depression (Geriatric depression scale, GDS ≤ 24)
Exclusion Criteria
2. Parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration.
3. Patients with PD who have history of severe side effect of Stalevo®.
20 Years
79 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Sun Ju Chung
Professor
Principal Investigators
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Sun Ju Chung, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-0241
Identifier Type: -
Identifier Source: org_study_id
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