Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
Phase 3
Completed
NCT01994109
| Condition | Sialorrhea |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC |
|---|
| Status | Completed |
|---|
| Enrollment | 187 participants |
|---|
| Interventions | MYOBLOC |
|---|
| Start date | Nov, 2013 |
|---|
| Completion date | Jan, 2016 |
|---|
| Results posted | Aug 15, 2019 |
|---|
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.
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
4 Weeks · g/minute
| MYOBLOC 2500 U | -0.37 ± 0.03 g/minute |
|---|
| MYOBLOC 3500 U | -0.36 ± 0.03 g/minute |
|---|
| Placebo | -0.07 ± 0.03 g/minute |
|---|
Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
4 weeks · score on a scale
| MYOBLOC 2500 U | 2.38 ± 0.12 score on a scale |
|---|
| MYOBLOC 3500 U | 2.45 ± 0.12 score on a scale |
|---|
| Placebo | 3.59 ± 0.13 score on a scale |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
Other trials for this condition
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.