Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects

Completed · Phase 3 · Has a placebo group

Conditions studied: Sialorrhea

In brief

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.

Key facts

Study ID

NCT01994109

Run by

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

People needed

187

Starts

2013-11-01

Expected to finish

2017-01-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — National City, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Boca Raton, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Carmel, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Elkridge, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Edison, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Port Royal, South Carolina, United States
• Study site — Cordova, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Kirkland, Washington, United States
• Study site — Tacoma, Washington, United States
• Study site — Irkutsk, Irkutsk Oblast, Russia

Full record on ClinicalTrials.gov

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