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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01565395
• Date of registration: 26/03/2012
• Prospective Registration: No
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) Xeomin
• Scientific title: Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: March 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01565395
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Parkinson Disease

Intervention(s)

Drug: Incobotulinum Toxin A

Drug: placebo

Primary Outcome(s)

Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo [Time Frame: 7 months]

Secondary ID(s)

2011P000304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merz Pharmaceuticals