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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supernus Pharmaceuticals, Inc.; US WorldMeds LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; rimabotulinumtoxinB

Criteria

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