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

NCT01994109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2026-04-21

Study results available
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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.

Conditions

  • Sialorrhea

Interventions

DRUG

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.

OTHER

PLACEBO

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Jonathan Rubin, MD · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • United States
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994109 on ClinicalTrials.gov