Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

NCT07061847 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB #: 24-0279
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the effectiveness of a new treatment in improving chronic migraine symptoms. This treatment involves a targeted lidocaine infusion into blood vessels in the skull to numb pain receptors, potentially leading to improvements in chronic migraine intensity, frequency, and duration.

Conditions

Migraine

Keywords

migraine; headache; intervention; lidocaine; endovascular

Outcome Measures

Primary Outcomes (1)

• Reduction in Monthly Migraine Headache Days

  To observe a ≥50% reduction in monthly migraine headache days in one month post intra-arterial lidocaine infusion into the bilateral middle meningeal artery.

  From enrollment to post-treatment at 3 months

Secondary Outcomes (9)

• ≥50% reduction in migraine headache intensity at 15 minutes, 2 hours, and 24 hours post procedure.

  15 minutes, 2 hours, and 24 hours post-procedure.

• Sustained freedom from headache pain >48hrs.

  >48hrs post treatment

• Percentage of patients achieving ≥75% and 100% reduction in monthly headache days at 1 month and 3 months

  At 1 month and 3 month post procedure

• Mean number of monthly migraine headaches days at 1 month and 3 months.

  From enrollment to 1 month and 3 months post procedure

• Mean change from baseline in the Global Assessment of Migraine Severity (GAMS) at 3 months

  From enrollment to 3 months post procedure

Study Arms (1)

Lidocaine

EXPERIMENTAL

All patients who meet eligilibity criteria at their baseline visit will be scheduled for the Lidocaine procedure.

Drug: Lidocaine (drug); Procedure: Lidocaine Procedure

Interventions

Lidocaine (drug) DRUG

The study intervention involves the use of 1% cardiac preservative-free lidocaine. Lidocaine is a local anesthetic commonly used in medical procedures to numb a specific area of the body. In this case, the lidocaine is formulated at a concentration of 1% and will be diluted to 50 mL with normal saline. This treatment is an intra-arterial bilateral lidocaine infusion into the middle meningeal artery (i.e. this is a lidocaine infusion into the brain blood vessels to turn off the pain receptors responsible for causing chronic headaches). Lidocaine is an FDA approved anesthetic (i.e. pain killer) used in common medical practice. Lidocaine, however, has not yet been approved by the FDA for this particular use. For this reason, the use of lidocaine in this study is considered investigational.

Lidocaine

Lidocaine Procedure PROCEDURE

All patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure.

Lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH).
• Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months)
• Medically refractory: defined as failure of ≥3 headache preventative treatments.
• Severely disabling (Migraine Disability Assessment \[MIDAS\] Tool score of ≥ 21 \[Grade IV\])
• Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale.
• Head pain is at least moderate-to-severe intensity (\>5 on a Visual Analog Scale) in ≥50% of headaches.
• Diagnosis of CDH for ≥ 12 months before screening based on medical records and/or patient self-report.
• Headache frequency: minimum 15 monthly headache days (MHD) on average across the 3 months prior to screening
• Patient reports to their provider intolerance or insufficient response with their current preventive treatment (i.e. insufficient reduction in headache frequency, duration, and severity on a standard treatment on a generally accept therapeutic dose for 6 weeks).
• On a stable concomitant medication and headache preventive for the 3 months prior to screening
• During Baseline Period:
• Must have ≥ 15 MHD based on the patient self-maintained diary data during the baseline period.
• Must have demonstrated \>75% compliance with diary data for the 28 day duration period, or longer if their baseline period carries on past this point.
• Must continue to meet eligibility criteria when reassessed at baseline completion visit

You may not qualify if:

• Recently started new migraine preventative treatment regimen within the past 3 months.
• Known allergy or sensitivity to lidocaine.
• Severe allergy/anaphylaxis to iodinated contrast dye.
• Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months)
• Chronic subdural hematoma
• Ischemic stroke or myocardial infarction within 3 months 8. History of renal insufficiency with Cr \> 1.5 within 3 months (will be retested during pre-surgical
• testing).
• \. History of abnormal ECGs within 3 months, specifically:
• Prolonged QT syndrome
• Use of medications that may prolong the QT interval such as: anti-nausea, anti-emetics, etc.
• \. Taking any antiarrhythmic medication (other than a beta blocker)
• \. Symptomatic peripheral arterial disease
• \. Known inherited or acquired bleeding diathesis (not including antiplatelet or anticoagulation medication)
• \. Evidence of active substance-related disorders, addictive disorders, or "recreational use" of illicit drugs.
• a. If any of these disorders have occurred within 12 months prior to screening, based on medical records, patient self-report, or positive urine drug test (except for prescribed medications that may result in a positive urine drug test).

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Neuroscience Institute at Great Neck

Great Neck, New York, 11021, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Jeffrey Katz, MD

CONTACT

5163257000; jkatz2@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)