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

NCT03381261 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017P001813
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

chronic migraine; trigeminal neuralgia; migraine surgery; nerve decompression

Outcome Measures

Primary Outcomes (1)

• Inflammatory Gene Expression in Chronic Migraine Patients With OnabotulinumtoxinA Injection Treatment Versus No Treatment

  In this split-person study, patients with chronic bilateral occipital migraines scheduled for a study-unrelated migraine surgery (occipital nerve decompression surgery) had one side of their head undergo treatment with onabotulinumtoxinA injection, while the other side of the head underwent no treatment. Occipital periosteum tissue of both injected and uninjected sides was collected during migraine surgery for targeted transcriptome profiling and genome-wide epigenome analyses of inflammatory gene expression using NanoString of 594 genes (579 immunology-related genes involved in adaptive/innate response, lymphocyte activation, cytokine/chemokine/NF-kB/TNF/interferon signalling, neutrophils, macrophages, cytotoxic T, NK, Th1, B and dendritic cells, and 15 internal reference controls). The effects size (ratio of geometric means) of expression of gene expression was evaluated between injected and uninjected sides.

  One year

Study Arms (1)

Botulinum toxin type A injection arm

EXPERIMENTAL

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

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Injection of Botulinum toxin type A in back of head

Also known as: Botox

Botulinum toxin type A injection arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Trigeminal Neuralgia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Lisa Gfrerer
• Organization: Weill Cornell Medicine

lig4013@med.cornell.edu

646.962.4250

Study Officials

• William G. Austen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Plastic and Reconstructive Surgery; Chief, Burn Surgery

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: December 1, 2017
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)