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Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

NCT03223298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-02-14

Study results available
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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.

Conditions

  • Pain, Head
  • Pain Syndrome
  • Temporomandibular Disorder
  • Myofascial Pain Syndrome
  • Myofascial Pain

Interventions

DRUG

Botulinum toxin type A

37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle

DRUG

0.9% Sodium Chloride Injection

1cc syringe

Sponsors & Collaborators

  • New York Presbyterian Hospital

    collaborator OTHER

  • Allergan

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Gwendolyn S Reeve, DMD · Weill Medical College of Cornell University

  • Michael Miloro, DMD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-03-13
Completion
2020-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223298 on ClinicalTrials.gov