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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Refractory Migraine, Headache

In brief

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)

Key facts

Study ID

NCT07361549

Run by

Daniel A Tonetti, MD

People needed

80

Starts

2026-03-01

Expected to finish

2031-07-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cooper University Health Care — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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