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