Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT02452606
Eligibility Criteria:
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®.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT02452606
Study Brief:
Protocol Section:
NCT02452606