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NCT01994109 · ClinicalTrials.gov registry record · Phase 3
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 study of Sialorrhea, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT01994109: Completed Phase 3 study of Sialorrhea, sponsored by Supernus Pharmaceuticals.
NCT01994109 is a Phase 3 study of Sialorrhea that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 187 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01994109, a Phase 3 study of Sialorrhea, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Change weight of expectorated saliva at a Week 4 post-injection visit.
Conditions Studied
Interventions
- DRUG MYOBLOC
- OTHER PLACEBO
Study Locations (20)
California
- - Loma Linda
- - Los Angeles
- - National City
Florida
- - Boca Raton
- - Port Charlotte
Maryland
- - Baltimore
- - Elkridge
New York
- - Albany
- - New York
Colorado
- - Aurora
District of Columbia
- - Washington D.C.
Indiana
- - Carmel
Michigan
- - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
What the finished NCT01994109 record still lists
NCT01994109 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Sialorrhea appearing as the primary indexed condition, and to 2 interventions - of which MYOBLOC is the first listed.
NCT01994109 names 20 study sites across 15 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT01994109 about?
NCT01994109 is a clinical study titled "Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects". 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, thereb...
What is the current status of trial NCT01994109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2013-11. Estimated completion is 2017-01.
What conditions does trial NCT01994109 study?
This clinical trial studies the following conditions: Sialorrhea.
What interventions are being tested in trial NCT01994109?
The interventions under investigation include: MYOBLOC (DRUG), PLACEBO (OTHER).
Who is sponsoring clinical trial NCT01994109?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01994109 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01994109's enrollment target sits among peer trials
187 1410th of 2000 higher than 589 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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