The Effect of Botulinum Toxin A on Headache Attributed to TMD

NCT03346252 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STUDY00000054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Secondary Headache Disorder

Outcome Measures

Primary Outcomes (3)

• Reduction in number of Headaches Attributed to TMD (HA)

  Self-report

  Every 12 weeks up to 1 year

• Reduction in Headache Impact Test-6 score (HIT-6)

  Self-report.

  Every 12 weeks up to 1 year

• Pressure Pain Threshold

  Using algometer at the temporalis and masseter muscles

  Every 12 weeks up to 1 year

Secondary Outcomes (3)

• Graded Chronic Pain Scale (GCPS), 1 and 6 months score

  Every 12 weeks up to 1 year

• Jaw Functional Limitation Scale

  Every 12 weeks up to 1 year

• Migraine Disability Assessment/ HA-TMD

  Every 12 weeks up to 1 year

Study Arms (1)

Botulinum Toxin type A

EXPERIMENTAL

Participants will be injected intramuscularly with total of 50 Units, 25 units of Botulinum A per temporalis muscle. The BTX injection will be prepared by dissolving 100 U vial in 2 ml of 0.9 % of Sodium Chloride (NaCl), yielding 25 U/ml. Each participant will receive 0.1 ml of BTX/NaCl mixture in 5 spots per temporalis muscle.

Drug: Botulinum Toxin type A

Interventions

Botulinum Toxin type A DRUG

All the participants meeting the inclusion criteria will be seen for a total of 4 visits and 3 phone interviews. Participants will complete a set of self-reporting questionnaires, assessing the disability associated with Headaches Attributed to TMD, and other pain-related TMD diagnoses, the impact of headaches on the quality of life, and psychosocial distress questionnaires. In addition, they will undergo 3 cycles of treatment, each 12 weeks apart.

Also known as: Botox

Botulinum Toxin type A

Eligibility Criteria

• Age: 18 Years - 74 Years
• Gender Eligibility Details: Restricted to female due to: a) higher prevalence of the condition in this group and b) small sample size
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (1)

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

MeSH Terms

Conditions

Headache Disorders, Secondary

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yoly M Gonzalez-Stucker, DDS, MS, MPH

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open Label.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: November 17, 2017
• Study Start: May 8, 2017
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

US (1)