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Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1

NCT06462781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-04

No results posted yet for this study

Summary

The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).

The main questions this study aims to answer: is this treatment safe for chronic migraine patients?

Participants will:

* Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
* Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
* Keep a log of their symptoms.

Conditions

  • Refractory Migraine

Interventions

DRUG

Lidocaine hydrochloride

Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time

DRUG

Methylprednisolone sodium succinate

Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time

Sponsors & Collaborators

  • Society of Vascular and Interventional Neurology

    collaborator UNKNOWN

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Daniel A Tonetti, MD · The Cooper Health System

  • Manisha Koneru, MD · The Cooper Health System

  • Hamza A Shaikh, MD · The Cooper Health System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-05-13
Completion
2025-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06462781 on ClinicalTrials.gov