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NCT03223298 · ClinicalTrials.gov registry record · Phase 3
Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles
A Phase 3 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT03223298: Completed Phase 3 study, sponsored by Weill Medical College of Cornell University.
NCT03223298 is a Phase 3 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03223298, a Phase 3 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
This study aims to determine whether the injection of botulinum toxin A or placebo (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain relief and improved jaw function in those who suffer from myofascial pain disorder. The study hypothesis is that botulinum toxin A injection is superior to placebo. The specific research questions are: 1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain? 2. Is the injection of botulinum toxin A superior to placebo for the improvement in function or quality of life (QOL)? 3. Are there any adverse effects that result from injection of botulinum toxin A or placebo into the masseters and temporalis muscles? Limited data exists to support the use of botulinum toxin A in the management of myofascial pain disorder of the masticatory region. Botulinum toxin A is not FDA approved for intra-muscular injection within the masticatory region. Its use in the masticatory region is considered off-label but performed without significant known complications. This study will provide the opportunity to quantitate and qualitate any complications in a large prospective sample of patients.
Primary Outcome
Visual Analog Scale ranging from "no pain (0)" to "pain as bad as it could possibly be (100)"
Interventions
- DRUG Botulinum toxin type A
- DRUG 0.9% Sodium Chloride Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-08-31 |
| Est. Completion | 2020-03-13 |
| Phase | Phase 3 |
What the finished NCT03223298 record still lists
NCT03223298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin type A is the first listed.
NCT03223298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03223298 about?
NCT03223298 is a clinical study titled "Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles". This study aims to determine whether the injection of botulinum toxin A or placebo (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain relief and improved jaw function in those who suffer from myofascial pain disorder. The study hypothesis is that botulinum toxi...
What is the current status of trial NCT03223298?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2018-08-31. Estimated completion is 2020-03-13.
What interventions are being tested in trial NCT03223298?
The interventions under investigation include: Botulinum toxin type A (DRUG), 0.9% Sodium Chloride Injection (DRUG).
Who is sponsoring clinical trial NCT03223298?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03223298's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 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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