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

A

Asan Medical Center

Status

Unknown

Conditions

Sleep Disorders
Parkinson Disease

Treatments

Drug: Stalevo®

Study type

Interventional

Funder types

Other

Identifiers

NCT02452606
2015-0241

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Stalevo®
Experimental group
Description:
Participants who are assigned to Stalevo Arm will take Stalevo® at bedtime for 3 month.
Treatment:
Drug: Stalevo®

Trial contacts and locations

0

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Central trial contact

Sun Ju Chung, Professor

Data sourced from clinicaltrials.gov

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