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

NCT01653132 | Completed Phase 2 Results

• 1 other identifier: 2011P00304
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sialorrhea

Keywords

PD

Outcome Measures

Primary Outcomes (2)

• Objectively Measured Salivary Weight

  Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.

  baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period

• Objectively Measured Percentage Salivary Weight

  Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.

  baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period

Secondary Outcomes (3)

• Change in Drooling Frequency and Severity Scale (DFSS) Scores

  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.

  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.

  between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period

Study Arms (2)

Incobotulinum Toxin A

EXPERIMENTAL

Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks

Drug: Incobotulinum Toxin A

Placebo

PLACEBO COMPARATOR

Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .

Drug: Placebo

Interventions

Incobotulinum Toxin A DRUG

Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks

Also known as: Xeomin

Incobotulinum Toxin A

Placebo DRUG

Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Swallowing function: Functional Oral Intake Scale (FOIS)\* of 5 or greater
• 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.
• 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.
• Women of child bearing age will need to be on a reliable method of birth control for the duration of the study.

You may not qualify if:

• For PD:
• Current use of Coumadin
• Concurrent significant medical illness
• History of myasthenia gravis or Lambert-Eaton Syndrome
• Ongoing substance abuse
• History of unreliable follow-up
• Past use of Xeomin® or other botulinum toxin preparations
• Cognitive impairment, defined as a score ≤ 23/30 on the Mini Mental Status Exam

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sialorrhea

Interventions

incobotulinumtoxinA; Sodium Chloride

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Pushpa Narayanaswami
• Organization: Beth Israel Deaconess Medical center

pnarayan@bidmc.harvard.edu

617-667-8130

Study Officials

• Pushpa Narayanaswami, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 30, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 14, 2017
• Results First Posted: December 14, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)