Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment

NCT07361549 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 24-279
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory Migraine; Headache

Keywords

headache; migraine; lidocaine; middle meningeal artery

Outcome Measures

Primary Outcomes (1)

• Change in Headache Impact Test-6 Scores

  Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms

  From baseline to 4 week follow-up

Study Arms (2)

Treatment

EXPERIMENTAL

Intra-arterial lidocaine

Drug: Lidocaine (drug)

Sham

SHAM COMPARATOR

Intra-arterial saline

Drug: Saline

Interventions

Lidocaine (drug) DRUG

Intra-arterial lidocaine infusion into bilateral middle meningeal arteries

Also known as: Xylocaine

Treatment

Saline DRUG

Intra-arterial saline infusion into bilateral middle meningeal arteries

Also known as: Fluids

Sham

Eligibility Criteria

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

You may qualify if:

• Age 18 years or above
• Referred for diagnostic angiography
• Diagnosis of intractable migraine
• Written informed consent able to be obtained from subject

You may not qualify if:

• Baseline HIT-6 score less than 60 (severe)
• Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• Concomitant intracranial pathology (eg, intracranial malignancy)
• Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
• Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia (nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine)
• Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
• Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
• Concurrent participation in another research protocol for investigation of an experimental therapy
• Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
• Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk
• Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery
• Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider

Sponsors & Collaborators

• Daniel A Tonetti, MD: lead

Study Sites (1)

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Lidocaine; Pharmaceutical Preparations; Sodium Chloride; Fluid Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Therapy; Therapeutics

Study Officials

• Manisha Koneru, MD

  The Cooper Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): July 1, 2031
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)