NCT07361549RecruitingPhase 2
Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment
Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 9 Sept 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Daniel A Tonetti, MD
- Diseases
- Migraine
- NCT number
- NCT07361549
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 9 Sept 2026 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant intracranial pathology (eg, intracranial malignancy)
- 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)
- Concurrent participation in another research protocol for investigation of an experimental therapy
Other illness
- 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
- Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
- Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
- Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
Other
- Baseline HIT-6 score less than 50
- Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
- Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cooper University Health Care Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.