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

July 11, 2016 updated by: Sun Ju Chung, Asan Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Levodopa/Carbidopa/Entacapone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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).
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.
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).
up to 3 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Sun Ju Chung, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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