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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02769793
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients between 31 and 80 years
* Parkinson disease (PD) was diagnosed by United Kingdom Parkinson disease brain bank criteria
* Patients receiving stable Levodopa treatment at least 2 weeks prior to baseline visit
* Delayed ON was confirmed by a specialized PD diary that records change in motor symptoms 90 minute after the first morning dose. Delayed ON is defined as delay of more than 40 minutes after the first morning dose for resolution of OFF state or experience of no ON state at least 1 per week.
Exclusion Criteria:
* Existence of cognitive decline hard to participate in the clinical trial or K-Minimental Status Exam score 24 or less
* Any contraindication of blood sampling
* Subjects with clinically significant psychiatric illness
* Subjects with a cancer or severe medical illness
* Lactating, pregnant, or possible pregnant
* History of malignant melanoma
* Subjects with narrow-angle glaucoma
* Subjects with hypersensitivity to levodopa or benserazide
* Subjects treated with non-selective monoamine oxidase (MAO)-B inhibitors
* Subjects with peptic ulcer, colitis, or gastrointestinal disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
31 Years
Maximum Age:
80 Years
Study:
NCT02769793
Study Brief:
Protocol Section:
NCT02769793