Trials / Completed
CompletedNCT01994109
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® (Part A) Followed by Open-Label, Multiple-Treatment With MYOBLOC® (Part B) in the Treatment of Troublesome Sialorrhea in Adult Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-01-01
- Completion
- 2017-01-01
- First posted
- 2013-11-25
- Last updated
- 2021-07-13
- Results posted
- 2019-08-15
Locations
34 sites across 3 countries: United States, Russia, Ukraine
Source: ClinicalTrials.gov record NCT01994109. Inclusion in this directory is not an endorsement.