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

CompletedPhase 4NCT03381261
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist
Conditions
Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center
Start date
2017-12-01
Primary completion
2023-08-01
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03381261