Clock and Narcolepsy Genetic Variants and the Effects of Stalevo� (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson Disease; Sleep Disorders
Intervention: Stalevo® (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s): Sun Ju Chung, Professor, Principal Investigator, Affiliation: Asan Medical Center
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.
Clinical Details
Official title: Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: The effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation (using Parkinson's Disease Sleep Scale)The effectiveness about improving the EDS(Excessive daytime sleepiness) in PD patients with motor fluctuation after taking Stalevo® in bedtime. The effectiveness about improving the morning motor symptoms in PD patients with motor fluctuation after taking Stalevo® in bedtime.
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients diagnosed with PD in accordance with UK Parkinson's Disease Society Brain
Bank Clinical Diagnostic Criteria (Hughes AJ, et al. 1992).
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:
1. Secondary parkinsonism
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®.
Locations and Contacts
Additional Information
Starting date: March 2015
Last updated: May 20, 2015
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