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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Beth Israel Deaconess Medical Center
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

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.