Phase 3
N=187
Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
Sialorrhea
Bottom Line
View on ClinicalTrials.gov: NCT01994109 ↗Enrolled (actual)
187
Serious AEs
11.5%
Results posted
Aug 2019
Primary outcome: Primary: Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) — -0.37; -0.36; -0.07 g/minute — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MYOBLOC (Drug); PLACEBO (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) |
-0.37; -0.36; -0.07 | <0.0001 sig |
| PRIMARY Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) |
2.38; 2.45; 3.59 | <0.0001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01994109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.