Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)
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 and Amyotrophic Lateral Sclerosis (ALS).
|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 and Amyotrophic Lateral Sclerosis (ALS)|
- 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
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Xeomin 70-100 units injected into the parotid and submandibular glands
Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
|Placebo Comparator: Placebo||
Participants will be recruited if they have Parkinson's disease, Parkinsonism, or ALS. 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) or the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALS-FRS-R) 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/ALS-FRS-R 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.
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Pushpa Narayanaswami, MD 617-667-4382|
|Contact: Tom R Geisbush, BA 617-667-3053 firstname.lastname@example.org|
|Principal Investigator: Pushpa Narayanaswami, MD|
|Principal Investigator:||Pushpa Narayanaswami, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||puspha narayanaswami, md||Beth Israel Deaconess Medical Center|