Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® (Part A) Followed by Open-Label, Multiple-Treatment With MYOBLOC® (Part B) in the Treatment of Troublesome Sialorrhea in Adult Subjects

Conditions
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Sialorrhea

Intervention / Treatment
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* Drug: MYOBLOC
* Other: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause Investigator sites will review entire list of inclusion criteria with potential subjects Exclusion Criteria: Any known prior exposure to botulinum toxin type B, or known adverse reaction or sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC solution components. Prior botulinum toxin treatment to the salivary glands at any time Investigator sites will review entire list of exclusion criteria with potential subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MYOBLOC 2500 U<br>Subjects will receive specified dose of MYOBLOC | Drug: MYOBLOC<br>* 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.<br>* Other names: rimabotulinumtoxinB, botulinum toxin type B;|
| Active Comparator: MYOBLOC 3500 U<br>Subjects will receive specified dose of MYOBLOC | Drug: MYOBLOC<br>* 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.<br>* Other names: rimabotulinumtoxinB, botulinum toxin type B;|
| Placebo Comparator: Placebo<br>Subjects will receive volume matched Placebo | Other: PLACEBO<br> <br> * Other names: volume-matched placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | Change weight of expectorated saliva at a Week 4 post-injection visit. | 4 Weeks | 
| Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | CGI-C was assessed on a 7-point scale ranging from very much improved to very much worse with 1 assigned to very much improved and 7 assigned to very much worse; ranging from a minimum score of 1 and a maximum score of 7. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sialorrhea, Parkinson's disease, Amyotrophic lateral sclerosis (ALS), stroke, neuroleptics