Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted this study to determine whether injections of Xeomin®, a type of botulinum toxin into the glands that produce saliva (one pair just below and in front of the ear and the other just under the jaw line) are safe and effective to treat excessive saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: incobotulinumtoxinA

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