The Effect of Botulinum Toxin A on Headache Attributed to TMD

• Status: Unknown status
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the effect of of botulinum toxin on the treatment of Headache Attributed to TMD.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Adults age 18 to 74 years old.

• Participants with Headaches Attributed to TMD based on Diagnostic Criteria for TMD (DC-TMD) criteria.

• A minimum of 15 headaches/events per month, for the last 3 months.

• Average pain intensity in the last month of ≥5 (0 to 10 scale) where 0 is no pain and 10 is the worst pain ever.

Exclusion Criteria:

• Pregnancy

• Participants with a history of neurological/neuromuscular disorders and bleeding disorders.

• Participants taking prescribed analgesics, muscle relaxants, amino glycosides, or anticholinesterases.

• Participants currently under BTX treatment.

• Participants currently under active treatment for TMD during the last month, which includes physical therapy and pharmacological management.