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 @ 1:52 PM
Ignite Modification Date:
2025-12-24 @ 1:52 PM
NCT ID:
NCT01565395
Eligibility Criteria:
Inclusion Criteria: Hypothesis: Xeomin® injections into the parotid and submandibular glands are safe and effective in the treatment of troublesome sialorrhea in patients with PD/Parkinsonism and ALS.
Inclusion criteria are as follows:
For ALS: 1. Patients diagnosed with ALS by el-Escorial Criteria, ages 20-80 with troublesome sialorrhea as defined below\*\*.
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\*\*.
\*\*Troublesome sialorrhea is defined as grade 3 or more (grade 3 is marked excess of saliva with some drooling) or more on the UPDRS Part 2 Sialorrhea grading scale:\[33\] (Appendix 1)
For both groups:
1. Swallowing function: FOIS scale\* 5 or greater (see appendix 1 for scale)
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 both PD and ALS:
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:
20 Years
Maximum Age:
80 Years
Study:
NCT01565395
Study Brief:
Protocol Section:
NCT01565395