Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment
RecruitingPhase 2
Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Age 18 years or above * Diagnosis of chronic migraine * Referred for diagnostic cerebral angiography to screen for intracranial pathology * Written informed consent able to be obtained from subject Exclusion Criteria: * Baseline HIT-6 score less than 50 * 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
About the study
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)
What is being tested
- Lidocaine (drug) (drug)
- Saline (drug)
Sponsor: Daniel A Tonetti, MD · Participants: 80 · Started: Sep 9, 2026
Contact the study team
- Daniel A Tonetti, MD · Phone: (855) 306-3876
Official record on ClinicalTrials.gov — NCT07361549
Locations in the U.S.
| New Jersey | Cooper University Health Care, Camden |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.