An interventional study of Stalevo® in Parkinson Disease and Sleep Disorders, sponsored by Asan Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-07-13.
Sponsored by Asan Medical Center · Not applicable, Interventional, and Treatment
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Asan Medical Center is the lead sponsor of 577 studies on the registry; 73 are open to participants now.
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Exclusion Criteria:
Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month.
Drug: 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.
Also known as: Levodopa/Carbidopa/Entacapone
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.
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.
Time frame: 2 years
The effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation (using Parkinson's Disease Sleep Scale)
To determine whether Stalevo® in bedtime improves the quality of sleep in PD patients with motor fluctuation using Parkinson's Disease Sleep Scale.
Time frame: 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.
Excessive daytime sleepiness (EDS) is characterized by persistent sleepiness and often a general lack of energy, even after apparently adequate or even prolonged night time sleep. EDS can be considered as one of features of sleep disturbance in parkinson's disease. It will be assessed using a composite measurement consisting of Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn and Yahr stage, Parkinson's Disease Sleep Scale (PDSS), Epworth Sleepiness Scale (ESS), Parkinson's Disease Wearing Off Questionnaire-9 (PDWOQ-9), and Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).
Time frame: 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.
To determine whether Stalevo® in bedtime improves the morning motor symptoms in PD patients with motor fluctuation. It will be assessed using a composite measurement consisting of Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn and Yahr stage, Parkinson's Disease Sleep Scale (PDSS), Epworth Sleepiness Scale (ESS), Parkinson's Disease Wearing Off Questionnaire-9 (PDWOQ-9), and Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).
Time frame: up to 3 months from enrollment
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Stalevo