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Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

NCT07061847 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-22

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the effectiveness of a new treatment in improving chronic migraine symptoms. This treatment involves a targeted lidocaine infusion into blood vessels in the skull to numb pain receptors, potentially leading to improvements in chronic migraine intensity, frequency, and duration.

Conditions

Interventions

DRUG

Lidocaine (drug)

The study intervention involves the use of 1% cardiac preservative-free lidocaine. Lidocaine is a local anesthetic commonly used in medical procedures to numb a specific area of the body. In this case, the lidocaine is formulated at a concentration of 1% and will be diluted to 50 mL with normal saline. This treatment is an intra-arterial bilateral lidocaine infusion into the middle meningeal artery (i.e. this is a lidocaine infusion into the brain blood vessels to turn off the pain receptors responsible for causing chronic headaches). Lidocaine is an FDA approved anesthetic (i.e. pain killer) used in common medical practice. Lidocaine, however, has not yet been approved by the FDA for this particular use. For this reason, the use of lidocaine in this study is considered investigational.

PROCEDURE

Lidocaine Procedure

All patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-03-10
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061847 on ClinicalTrials.gov