NCT02452606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

May 14, 2015

Last Update Submit

July 11, 2016

Conditions

Parkinson DiseaseSleep Disorders

Keywords

Stalevosleep disturbancecentral circadian clocknarcolepsy

Outcome Measures

Primary Outcomes (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.

    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 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)

    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.

    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.

    up to 3 months from enrollment

Study Arms (1)

Stalevo®

EXPERIMENTAL

Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month.

Drug: Stalevo®

Interventions

Stalevo®DRUG

* 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.

Also known as: Levodopa/Carbidopa/Entacapone
Stalevo®

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseSleep Wake DisordersParasomniasNarcolepsy

Interventions

StalevoLevodopa

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDisorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Sun Ju Chung, Professor

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Ju Chung, Professor

CONTACT

82-2-3010-3988sunjubrain@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 22, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

KR(1)