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:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT03433950
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic Parkinson's disease fulfilling UK Brain Bank clinical criteria.
* Treatment with chronic levodopa (levodopa treatment for ≥ 3 years).
* Rise in "OFF" systolic blood pressure exceeding 50% of baseline "ON" systolic blood pressure as shown by at home monitoring.
* History of "wearing off" prior to 4 hours after the previous levodopa dose per patient report or chart documentation.
Exclusion Criteria:
* Daily beta-blocker therapy.
* Diabetes mellitus, autonomic neuropathy, or other condition known to alter autonomic functions.
* Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of \< 16
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03433950
Study Brief:
Protocol Section:
NCT03433950