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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
Sponsor:
Information provided by (Responsible Party):
Sun Ju Chung, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Sleep Disorders Drug: Stalevo® Not Applicable

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stalevo®
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.
Other Name: Levodopa/Carbidopa/Entacapone


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Eligibility Criteria
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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
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®.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sun Ju Chung, Professor 82-2-3010-3988 sunjubrain@gmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Sun Ju Chug, Professor    82-2-3010-3988    sunjubrain@gmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sun Ju Chung, Professor Asan Medical Center
More Information
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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
Keywords provided by Sun Ju Chung, Asan Medical Center:
Stalevo
sleep disturbance
central circadian clock
narcolepsy
Additional relevant MeSH terms:
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Parkinson Disease
Sleep Wake Disorders
Parasomnias
Narcolepsy
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
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