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Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
Sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
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.
Official title: Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® Followed by Open-Label, Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
187
Start Date
2013-11
Completion Date
2017-01
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
MYOBLOC
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.
PLACEBO
Locations (34)
Loma Linda, California, United States
Los Angeles, California, United States
National City, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Port Charlotte, Florida, United States
Carmel, Indiana, United States
Baltimore, Maryland, United States
Elkridge, Maryland, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Edison, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Port Royal, South Carolina, United States
Cordova, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Kirkland, Washington, United States
Tacoma, Washington, United States
Irkutsk, Irkutsk Oblast, Russia
Vsevolozhsk, Leningradskaya Oblast', Russia
Saint Petersburg, Petrodvorets, Russia
Krasnoyarsk, Russia
Dnipropetrovsk, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Lviv, Ukraine
Rivne, Ukraine
Uzhhorod, Ukraine