Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism
Condition: Sialorrhea
MeSH terms: Sialorrhea; Parkinson Disease; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 2

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 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.
    

Intervention name(s): Incobotulinum Toxin A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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 .
Other intervention name(s): Xeomin; Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PD