Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)

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.