Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment (LIGHT 2)

Daniel A Tonetti, MD

Status and phase

Begins enrollment this month

Phase 2

Conditions

Refractory Migraine

Headache

Treatments

Drug: Saline

Drug: Lidocaine (drug)

Study type

Interventional

Funder types

Other

Identifiers

NCT07361549

24-279

Details and patient eligibility

About

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)

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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