Phase 3
Completed N=187
Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
Source: ClinicalTrials.gov NCT01994109 ↗Enrolled (actual)
187
Serious AEs
11.5%
Results posted
Aug 2019
Primary outcomePrimary: Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) — -0.37; -0.36; -0.07 g/minute — p=<0.0001
◆ Published Evidence
Highly cited
240citations · ~11 / year
A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease.
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.
Linked Publications (3)
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A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease.
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Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial.
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Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.