Back to results(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Primary Purpose
Migraine
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional basic science trial for Migraine focused on measuring chronic migraine, trigeminal neuralgia, migraine surgery, nerve decompression
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Botulinum toxin type A injection arm
Arm Description
All patients will be injected with Botulinum toxin on one side of the back of the head.
Outcomes
Primary Outcome Measures
molecular markers in discarded tissue of migraine patients
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03381261
First Posted
December 18, 2017
Last Updated
December 5, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03381261
Brief Title
(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
Official Title
Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
chronic migraine, trigeminal neuralgia, migraine surgery, nerve decompression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin type A injection arm
Arm Type
Experimental
Arm Description
All patients will be injected with Botulinum toxin on one side of the back of the head.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botox
Intervention Description
Injection of Botulinum toxin type A in back of head
Primary Outcome Measure Information:
Title
molecular markers in discarded tissue of migraine patients
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G. Austen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
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