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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01653132
First received: July 25, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Sialorrhea
Drug: Xeomin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Objectively Measured Salivary Volume [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xeomin
Xeomin 70-100 units injected into the parotid and submandibular glands
Drug: Xeomin
Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
Placebo Comparator: Placebo Drug: Placebo
Placebo

Detailed Description:

Participants will be recruited if they have Parkinson's disease, Parkinsonism. Inclusion and exclusion criteria are summarized below. Participants will be screened at the first visit to make sure they are eligible for the trial. They will then undergo baseline testing including neurologic evaluation, questions to assess their memory and cognitive status and evaluation of their disease status using parts of the Unified Parkinsons's Disease Ratings Scale (UPDRS) that are routinely used to follow disease progression. They will be given a questionnaire to evaluate the severity of their drooling. Their saliva production will be measured by having them spit into a cup for 5 minutes, twice.

At the first visit, after making sure they are eligible for the study and performing the baseline testing and procedures, they will be given either Xeomin or placebo (saline injections without medication) injections in the 4 glands that produce saliva. They will not know which injection they received. This visit will take about 2 hours. They will be followed up every month and asked about side effects, have neurologic evaluation and UPDRS testing and fill-in the questionnaire for drooling severity. Saliva volume will be measured as done at the first visit. At either Month 4 or 5, participants will receive the second injection. This will be a "cross-over" injection, i.e., if they received Xeomin at the first injection they will receive saline at the second and vice versa. Thus, all participants will receive the study medication Xeomin, either as the first injection or the second injection at 4 months or 5 months. The follow up after the second injection will be one monthly visit for 3 months, with similar evaluations as described above. The follow-up visit will take about 1 hour each.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653132

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Pushpa Narayanaswami, MD    617-667-4382      
Contact: Sung J Yim, BA    617-667-3053    syim1@bidmc.harvard.edu   
Principal Investigator: Pushpa Narayanaswami, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Pushpa Narayanaswami, MD Beth Israel Deaconess Medical Center
Principal Investigator: puspha narayanaswami, md Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01653132     History of Changes
Other Study ID Numbers: 2011P00304
Study First Received: July 25, 2012
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
PD

Additional relevant MeSH terms:
Parkinson Disease
Sialorrhea
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 27, 2014