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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03381261

Collaborator

Beth Israel Deaconess Medical Center (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Botulinum toxin type A	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist

Actual Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum toxin type A injection arm All patients will be injected with Botulinum toxin on one side of the back of the head.	Drug: Botulinum toxin type A Injection of Botulinum toxin type A in back of head Other Names: Botox

Arm

Intervention/Treatment

Experimental: Botulinum toxin type A injection arm

All patients will be injected with Botulinum toxin on one side of the back of the head.

Drug: Botulinum toxin type A

Injection of Botulinum toxin type A in back of head

Other Names:

Botox

Outcome Measures

Primary Outcome Measures

molecular markers in discarded tissue of migraine patients [one year]
molecular markers in discarded tissue of migraine surgery will be analyzed. Gene Expression CodeSet profiling 594 genes; 579 immunology-related human genes + 15 internal reference controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.