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Neurotoxin

Botulinum toxin type A for Myofascial Pain Syndrome

Phase 3

Waitlist Available

Led By Gwendolyn S Reeve, DMD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention, 1 month post-intervention, 2 months post-intervention, 3 months post-intervention

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial is testing whether botulinum toxin A injections into the masseter and temporalis muscles can relieve pain and improve jaw function for people with myofascial pain disorder. The hypothesis is that botulinum toxin A is better than a placebo.

Eligible Conditions

Headache
Myofascial Pain Syndrome
Temporomandibular Joint Disorder
Complex Regional Pain Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention, 1 month post-intervention, 2 months post-intervention, 3 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention, 1 month post-intervention, 2 months post-intervention, 3 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention, 1 month post-intervention, 2 months post-intervention, 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS)

Secondary study objectives

Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)

Change in Objectively Assessed Quality of Life as Measured by Short Form 36

Jaw Function as Measured by Jaw Function Limitation Scale

Side effects data

From 2016 Phase 4 trial • 42 Patients • NCT02321436

Head injury

Insomnia

Pain

Asthma

Tachycardia

Constipation

Pyrexia

Cough

Hypertensive crisis

Pneumonia

Vomiting

Fall

Hypokalaemia

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Dysport ® 500 U

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Botulinum Toxin Type AExperimental Treatment1 Intervention

The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.

Group II: 0.9% Sodium Chloride InjectionPlacebo Group1 Intervention

The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum toxin type A

FDA approved

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