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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381261
• Other study ID #: 2017P001813
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Botulinum toxin type A
Injection of Botulinum toxin type A in back of head

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year