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

NCT01994109

CompletedPhase 3

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

Conditions: Sialorrhea

Interventions: MYOBLOC, PLACEBO

Countries: United States, Russia, Ukraine

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
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
  • + 4 more on CT.gov