Status:
COMPLETED
(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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.
Detailed Description
Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03381261
Start Date
December 1 2017
End Date
December 1 2023
Last Update
March 24 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114