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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT03651856
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
2. A positive response to item 14 of the UPDRS, part 2.
3. Age range 18-80
4. Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
5. Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
6. Stable on PD medications for ≥ 3 months
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Exclusion Criteria:
1. Intolerance to drug class
2. Mini-Mental Status Examination \<26/30
3. No observable episodes of freezing of gait despite common visual cues
4. Not on stable PD medications for 3 months
5. Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
6. Current use of monoamine oxidase inhibitor (MAO-I)
7. Hypersensitivity to drug class
8. Narrow angle glaucoma
9. Pheochromocytoma
10. Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
11. Patients with uncontrolled hypertension.
12. Patients with a history of symptomatic tachyarrhythmias.
13. Presence of uncontrolled depression and suicidal ideation.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03651856
Study Brief:
Protocol Section:
NCT03651856