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

July 24, 2019

Overview

 

The (Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist trial compares the symptoms of people treated with and without botox injections for chronic migraine patients using molecular studies.

 

Study Information

 

Patients who meet the inclusion criteria will be injected with Botulinum toxin (Botox) on one side of the back of the head prior to surgery. Then, the study will evaluate the effects the botox has on tissues. Estimated enrollment is 50 patients and the estimated completion date is December 2019.

 

Inclusion Criteria

 

  • Ages 18-65
  • 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, intrauterine 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.

 

Location

 

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

 

Sponsors/Collaborators

 

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

 

Contact/Principal Investigator: William G Austen: (617) 459-9106

wausten@partners.org

Contact: Lisa Gfrerer: (617) 459-9106

lgfrerer@partners.org

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