Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02452606
• Other study ID #: 2015-0241
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2015
• Last updated: July 11, 2016
• Start date: March 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2016
• Source: Asan Medical Center
• Contact: Sun Ju Chung, Professor
• Phone: 82-2-3010-3988
• Email: sunjubrain[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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®.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Narcolepsy
• Parasomnias
• Parkinson Disease
• Sleep Disorders
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	Yes
Secondary	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.	up to 3 months from enrollment.	No
Secondary	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).	up to 3 months from enrollment.	No
Secondary	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).	up to 3 months from enrollment	No