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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT01653132
Eligibility Criteria:
Inclusion Criteria:
* For PD/ Parkinsonism: 1. PD, Multiple Systems Atrophy (MSA), or Progressive Supranuclear Palsy (PSP) diagnosed by clinical criteria, ages 20-80 with troublesome sialorrhea as defined below\*\*.
* Sialorrhea that patients or their families or treating physicians think is troublesome
1. Swallowing function: Functional Oral Intake Scale (FOIS)\* of 5 or greater
2. If patients have been treated with other medications for sialorrhea earlier, they should be off the medications at least 4 weeks prior to the baseline evaluation.
3. If they are on other medications for sialorrhea at the time of the baseline evaluation, the doses will be held stable throughout the period of the study.
4. Women of child bearing age will need to be on a reliable method of birth control for the duration of the study.
Exclusion Criteria:
* For PD:
1. Current use of Coumadin
2. Concurrent significant medical illness
3. History of myasthenia gravis or Lambert-Eaton Syndrome
4. Ongoing substance abuse
5. History of unreliable follow-up
6. Past use of Xeomin® or other botulinum toxin preparations
7. Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01653132
Study Brief:
Protocol Section:
NCT01653132