Recruiting

Phase 2

LidocaineLocalized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment

Sponsor:

Daniel A Tonetti, MD

Code:

NCT07361549

Conditions

Refractory Migraine

Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine (drug)

Saline

Study Details

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

Study ID

NCT07361549

Start date

Sep 9, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Intra-arterial lidocaine

sham comparator: Sham

Intra-arterial saline

Interventions

Lidocaine (drug)

Intra-arterial lidocaine infusion into bilateral middle meningeal arteries

Saline

Intra-arterial saline infusion into bilateral middle meningeal arteries

Primary outcome measure

Change in Headache Impact Test-6 Scores (1 Month) [ Time Frame: From baseline to 1 month follow-up ]

Central Contacts and Locations

Central contacts

Daniel A Tonetti, MD

(855) 306-3876 tonetti-daniel@cooperhealth.edu

Manisha Koneru, MD

koneru-manisha@cooperhealth.edu

Locations

Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 08103

More Information

Sponsor

Daniel A Tonetti, MD

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

headache
migraine
lidocaine
middle meningeal artery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Daniel A Tonetti, MD on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.