Parkinson DiseaseNCT02452606
Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
A study testing Stalevo® in people with Parkinson Disease and Sleep Disorders, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Parkinson Disease, Sleep Disorders
- What is being tested?
- Stalevo®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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®.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Sun Ju Chug, Professor, 82-2-3010-3988, sunjubrain@gmail.com
About this study
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.
- Conditions
- Parkinson Disease, Sleep Disorders
- Being tested
- Stalevo®
- Keywords
- Stalevo, sleep disturbance, central circadian clock, narcolepsy
- Medical subject headings
- Parkinson Disease, Sleep Wake Disorders, Parasomnias, Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stalevo®Drug
Also called Levodopa/Carbidopa/Entacapone
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Stalevo® | Experimental | Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month. Receives: Drug: Stalevo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: up to 3 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Ju Chung, Asan Medical Center
- Investigators
- Sun Ju Chung, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452606
- Sponsor's protocol ID
- 2015-0241
- Status last verified
- Jul 2016
- First submitted
- 14 May 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02452606
- Acronym / sponsor ID
- 2015-0241
- Conditions
- Parkinson Disease, Sleep Disorders
- Keywords
- Stalevo, sleep disturbance, central circadian clock, narcolepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stalevo® | Experimental | Drug: Stalevo®Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stalevo®Also: Levodopa/Carbidopa/Entacapone* 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. | Drug | Stalevo® |
Primary outcome
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.
3 secondary outcomes
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Ju Chung, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stalevo® in people with Parkinson Disease and Sleep Disorders, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Ju Chung, Professor (82-2-3010-3988, sunjubrain@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.