Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT02452606 |
Recruitment Status : Unknown
Verified July 2016 by Sun Ju Chung, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : May 22, 2015
Last Update Posted : July 13, 2016
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Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease Sleep Disorders | Drug: Stalevo® | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | May 2017 |
Estimated Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
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Experimental: Stalevo®
Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month.
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Drug: Stalevo®
Other Name: 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. [ 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.
- The effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation (using Parkinson's Disease Sleep Scale) [ Time Frame: up to 3 months from enrollment. ]To determine whether Stalevo® in bedtime improves 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. [ Time Frame: up to 3 months from enrollment. ]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).
- The effectiveness about improving the morning motor symptoms in PD patients with motor fluctuation after taking Stalevo® in bedtime. [ Time Frame: up to 3 months from enrollment ]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).

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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 1-4.
- 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 ≥15.
- 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®.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452606
Contact: Sun Ju Chung, Professor | 82-2-3010-3988 | sunjubrain@gmail.com |
Korea, Republic of | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 05505 | |
Contact: Sun Ju Chug, Professor 82-2-3010-3988 sunjubrain@gmail.com |
Principal Investigator: | Sun Ju Chung, Professor | Asan Medical Center |
Responsible Party: | Sun Ju Chung, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT02452606 |
Other Study ID Numbers: |
2015-0241 |
First Posted: | May 22, 2015 Key Record Dates |
Last Update Posted: | July 13, 2016 |
Last Verified: | July 2016 |
Stalevo sleep disturbance central circadian clock narcolepsy |
Parkinson Disease Sleep Wake Disorders Parasomnias Narcolepsy Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neurologic Manifestations Mental Disorders Disorders of Excessive Somnolence |
Sleep Disorders, Intrinsic Dyssomnias Levodopa Carbidopa Entacapone Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Catechol O-Methyltransferase Inhibitors |