(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Migraine

Treatments

Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Other

Identifiers

NCT03381261

2017P001813

Details and patient eligibility

About

To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.

Full description

Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.

Enrollment

37 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-65 years
Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles
Patient is capable and willing to provide informed consent
Female subjects of child bearing potential must have a negative pregnancy test at enrollment and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms or partner has had a vasectomy) for three months following injections of Botox
Patients referred by their primary Neurologist to the study surgeon and who are determined to be candidates for surgical decompression of extracranial sensory nerves.
Patient agrees to abstain from protocol-specific excluded medications beginning 14 days prior to the decompression surgery.

Exclusion criteria

Patient has hypersensitivity reactions or other intolerance to Botox
Patient is pregnant or trying to become pregnant with the timeframe of the study.
Infection at proposed injection sites.