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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism

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.

Detailed Summary:

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.


Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome:

  • Objectively Measured Salivary Weight [ Time Frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period ]
    Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.
  • Objectively Measured Percentage Salivary Weight [ Time Frame: baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period ]
    Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.


Original Primary Outcome: Objectively Measured Salivary Volume [ Time Frame: 7 months ]

Change in objectively measured salivary volume between baseline and one month post-injection in the Xeomin group as compared to placebo


Current Secondary Outcome:

  • 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 ]

    measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.Drooling Frequency and Severity Score. The Drooling Score equals the sum of the Severity and Frequency sub-scores. The range is 2-9, higher numbers represent worse drooling Drooling Severity Scale

    1. = Never drools, dry
    2. = Mild-drooling, only lips wet
    3. = Moderate- drool reaches the lips and chin
    4. = Severe- drool drips off chin & onto clothing
    5. = Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale

    1. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling

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


Original Secondary Outcome:

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: July 25, 2012
Date Started: March 2012
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017