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

NCT ID
NCT07361549
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Daniel A Tonetti, MD
Conditions
Headache, Refractory Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial

Enrollment: 80 participants (Estimated).

What is being studied

  • Intervention: Acetanilides
  • Intervention: Amides
  • Intervention: Amines
  • Intervention: Anilides
  • Intervention: Aniline Compounds
  • Intervention: Chlorides
  • Intervention: Chlorine Compounds
  • Intervention: Drug Therapy
  • Intervention: Fluid Therapy
  • Intervention: Hydrochloric Acid
  • Intervention: Inorganic Chemicals
  • Intervention: Lidocaine
  • Drug: Lidocaine (drug)
  • Intervention: Organic Chemicals
  • Intervention: Pharmaceutical Preparations
  • Drug: Saline
  • Intervention: Sodium Chloride
  • Intervention: Sodium Compounds
  • Intervention: Therapeutics

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New Jersey, United States: 1

Sample of listed locations

  • Cooper University Health Care — Camden, New Jersey, 08103, United States — Recruiting

Study details

Start date
September 9, 2026
Primary completion date
December 1, 2030
Completion date
July 1, 2031
First posted
January 23, 2026
Collaborators
SNIS Foundation, Stryker Neurovascular

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07361549
Registry last updated
October 1, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07361549 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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