CompletedPhase 3

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

United States187 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)

Timeframe: 4 Weeks

Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)

Timeframe: 4 weeks

Trial details

NCT IDNCT01994109

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2019-05-02

View on ClinicalTrials.gov More Sialorrhea trials