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Neurotoxin

Botulinum Toxin type A for Headache Disorders

Phase < 1
Waitlist Available
Led By Yoly M Gonzalez-Stucker, DDS, MS, MPH
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age 18 to 74 years old.
Participants with Headaches Attributed to TMD based on Diagnostic Criteria for TMD (DC-TMD) criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks up to 1 year
Awards & highlights

Study Summary

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

Eligible Conditions
  • Headache Disorders

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Reduction in Headache Impact Test-6 score (HIT-6)
Reduction in number of Headaches Attributed to TMD (HA)
Secondary outcome measures
Graded Chronic Pain Scale (GCPS), 1 and 6 months score
Jaw Functional Limitation Scale
Temporomandibular Joint Disorders

Side effects data

From 2012 Phase 3 trial • 196 Patients • NCT01313767
4%
Nasopharyngitis
4%
Pain in extremity
3%
Diarrhoea
3%
Vomiting
3%
Back pain
3%
Oedema peripheral
2%
Cholecystitis acute
2%
Abdominal distension
2%
Dyspepsia
2%
Nausea
2%
Upper respiratory tract infection
2%
Musculoskeletal pain
2%
Injection site haematoma
2%
Pyrexia
1%
Hepatitis toxic
1%
Intraventricular haemorrhage
1%
Pulmonary tuberculosis
1%
Renal failure
1%
Consitipation
1%
Dizziness
1%
Headache
1%
Myocardial infarction
1%
Pneumonia
1%
Convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Meditoxin®
Botox®

Trial Design

1Treatment groups
Experimental Treatment
Group I: Botulinum Toxin type AExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
245 Previous Clinical Trials
49,448 Total Patients Enrolled
Yoly M Gonzalez-Stucker, DDS, MS, MPHPrincipal InvestigatorUniversity at Buffalo

Frequently Asked Questions

~3 spots leftby Mar 2025