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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01653132
• Date of registration: 25/07/2012
• Prospective Registration: No
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
• Scientific title: Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
• Date of first enrolment: March 2012
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01653132
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Pushpa Narayanaswami, MD
• Affiliation: Beth Israel Deaconess Medical Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sialorrhea

Intervention(s)

Drug: Incobotulinum Toxin A

Drug: Placebo

Primary Outcome(s)

Objectively Measured Percentage Salivary Weight [Time Frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period]

Objectively Measured Salivary Weight [Time Frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period]

Secondary Outcome(s)

Change in Drooling Frequency and Severity Scale (DFSS) Scores [Time Frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period]

Number of Participants With Response, Defined as Subjects With = 2 Point Improvement in the DFSS Scores. [Time Frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period]

Number of Participants With Response, Defined as Subjects With = 20% Reduction in Saliva Volume. [Time Frame: between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period]

Secondary ID(s)

2011P00304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01653132