Conditions: Sialorrhea
Keywords: Sialorrhea Parkinson's disease Amyotrophic lateral sclerosis (ALS) stroke neuroleptics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 187
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.

Detailed description:

Arms:
arm 1: Subjects will receive specified dose of MYOBLOC arm 2: Subjects will receive specified dose of MYOBLOC arm 3: Subjects will receive volume matched Placebo

Interventions: intervention 1: MYOBLOC intervention 2: PLACEBO
Intervention descriptions: intervention 1: MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use. intervention 2: None

Protocol document: