Bilateral middle meningeal artery lidocaine infusion to treat chronic, debilitating migraines

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

This Phase 2 procedure will test whether injecting lidocaine into the middle meningeal arteries can reduce the frequency, intensity, and duration of chronic, treatment‑resistant migraines in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Northwell Health (Academic / other)
• Locations: 1 site (Great Neck, New York)
• Trial ID: NCT07061847 on ClinicalTrials.gov

What this trial studies

This interventional Phase 2 study delivers a targeted intra-arterial infusion of lidocaine into both middle meningeal arteries using an endovascular procedure. Eligible adults with chronic daily headache and prior failure of multiple preventive treatments will have data collected before and after the procedure to track changes in monthly headache days, pain intensity, and headache duration. Outcomes will include patient‑reported measures (e.g., MIDAS, VAS, GAMS) and headache frequency over set follow‑up intervals. The protocol builds on prior safe use of intra-arterial lidocaine in other brain procedures but applies the approach specifically to refractory migraine.

Who should consider this trial

Good fit: Adults aged 18–75 with chronic daily headache (≥15 headache days/month for ≥3 months), severe disability (MIDAS ≥21 and GAMS 6–7), failure of at least three preventive treatments, and moderate‑to‑severe pain in at least half of their headaches are the intended candidates.

Not a fit: People with infrequent migraines, those who respond to conventional therapies, or patients with contraindications to endovascular procedures or lidocaine are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the treatment could meaningfully reduce how often and how badly migraines strike for people who have not responded to standard preventive therapies.

How similar studies have performed: Intra-arterial lidocaine has been used safely in other neurovascular settings, but using bilateral middle meningeal artery lidocaine specifically for chronic migraine is a novel application with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH).

   1. Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months)
   2. Medically refractory: defined as failure of ≥3 headache preventative treatments.
   3. Severely disabling (Migraine Disability Assessment \[MIDAS\] Tool score of ≥ 21 \[Grade IV\])
   4. Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale.
   5. Head pain is at least moderate-to-severe intensity (\>5 on a Visual Analog Scale) in ≥50% of headaches.
2. Diagnosis of CDH for ≥ 12 months before screening based on medical records and/or patient self-report.
3. Headache frequency: minimum 15 monthly headache days (MHD) on average across the 3 months prior to screening
4. 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).
5. On a stable concomitant medication and headache preventive for the 3 months prior to screening

During Baseline Period:

1. Must have ≥ 15 MHD based on the patient self-maintained diary data during the baseline period.
2. 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.
3. Must continue to meet eligibility criteria when reassessed at baseline completion visit

Exclusion Criteria:

1. Recently started new migraine preventative treatment regimen within the past 3 months.
2. Known allergy or sensitivity to lidocaine.
3. Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure)
4. Severe allergy/anaphylaxis to iodinated contrast dye.
5. Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months)
6. Chronic subdural hematoma
7. 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).

9\. History of abnormal ECGs within 3 months, specifically:

1. Prolonged QT syndrome
2. Use of medications that may prolong the QT interval such as: anti-nausea, anti-emetics, etc.

   10\. Taking any antiarrhythmic medication (other than a beta blocker)

   11\. Symptomatic peripheral arterial disease

   12\. Known inherited or acquired bleeding diathesis (not including antiplatelet or anticoagulation medication)

   13\. 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).

14\. Active chronic pain syndromes (e.g., fibromyalgia and chronic pelvic pain).

15\. History of major psychiatric disorder or current evidence of moderately severe or severe depression based on a Patient Health Questionnaire-9 (PHQ-9) total score ≥ 15 at screening.

a. Subjects with history of anxiety disorder and/or major depressive disorder with PHQ-9 \< 15) and are taking no more than 1 medication, for each disorder, for at least 2 months prior to screening may be considered.

16\. If the subject is pregnant, planning on pregnancy during the duration of the study, or planning on making their partner pregnant will be excluded from the study unless proper contraception is in place.

17\. Any diagnosis at the discretion of the investigator that would make the patient unfit.

Where this trial is running

Great Neck, New York

• Neuroscience Institute at Great Neck — Great Neck, New York, United States (Recruiting)

Study contacts

• Study coordinator: Jeffrey Katz, MD

Conditions Migraine; migraine; headache; intervention; lidocaine; endovascular