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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines (NCT07061847) is a Phase 2 interventional studying Migraine, sponsored by Northwell Health. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Migraine and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Lidocaine (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.

PROCEDURE

Lidocaine Procedure

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Neuroscience Institute at Great Neck
Great Neck, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07061847), the sponsor (Northwell Health), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07061847 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07061847?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07061847?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07061847. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07061847. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.