MigrainePhase 2NCT07061847
Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
A Phase 2 study testing Lidocaine (drug) and Lidocaine Procedure in people with Migraine, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Lidocaine (drug) and Lidocaine Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Recently started new migraine preventative treatment regimen within the past 3 months.
- Known allergy or sensitivity to lidocaine.
- Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure)
- 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
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- 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:
- Prolonged QT syndrome
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neuroscience Institute at Great Neck
Great Neck, New York, 11021
Nicholas Zumba, 516-473-5807, nzumba@northwell.edu
About this study
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.
Read the detailed description
Given the current literature and using intent-to-treat clinical judgement, the research team believes that the treatment offered in this study may offer a promising benefit to treatment resistant migraine patients. Despite modest advances in drug therapy, some patients still suffer from chronic migraines. Therefore, the headache medicine community continues to search for alternative treatments in the form of research.
The research team is conducting a prospective observational study to gather data before and after this treatment is administered to determine whether there is improvement in migraine duration, intensity, and frequency.
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.
This is NOT the first time this procedure has been performed. Intra-arterial lidocaine infusion has been used safely during the treatment of other brain diseases. Infusing brain vessels with lidocaine is not new technique. The treatment offered in this study is new for the treatment of migraines. This particular treatment has been performed successfully in the small group studies that the study investigators are modeling after. The investigative neuro-interventionists have been rigorously trained for this approach and hold a minimum of double board certifications. This team is experienced in using these techniques for other brain diseases and have successfully performed this specific procedure in a select group of early patients. Collectively, the team holds over 45+ years of experience in performing neuro-endovascular procedures.
During the intra-arterial infusion of lidocaine for treatment of a subdural procedure, an incidental finding noted that patients had reduced headache intensity following this treatment.
Therefore, this technique has been re-purposed in this study to treat chronic migraine sufferers. The procedure is considered investigational because lidocaine is not yet FDA-approved for this specific use. Although several studies have demonstrated that this approach is a safe and tolerable treatment for chronic migraine, there is still insufficient evidence to incorporate it into the current day standard of care protocol.
Ultimately, the purpose of this study is to explore this approach to and determine if this treatment can induce a significant improvement in chronic migraine, intensity, duration, and frequency.
- Conditions
- Migraine
- Being tested
- Lidocaine (drug), Lidocaine Procedure
- Keywords
- migraine, headache, intervention, lidocaine, endovascular
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ProcedureProcedure or surgery
All patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | All patients who meet eligilibity criteria at their baseline visit will be scheduled for the Lidocaine procedure. Receives: Drug: Lidocaine (drug); Procedure: Lidocaine Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes, 2 hours, and 24 hours post-procedure.
Sustained freedom from headache pain >48hrs.
Measured: >48hrs post treatment
Percentage of patients achieving ≥75% and 100% reduction in monthly headache days at 1 month and 3 months
Measured: At 1 month and 3 month post procedure
Mean number of monthly migraine headaches days at 1 month and 3 months.
Measured: 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
Measured: From enrollment to 3 months post procedure
Percent with improvement in Migraine Disability Assessment (MIDAS) at 3 months from severe disability (Grade IV, score ≥21) to no moderate disability (Grade I to III, score 0-21)
Measured: From enrollment to 3 month post procedure
Percent Headache Impact Test (HIT)-6 score <50 at 3 months.
Measured: From enrollment to 3 months post procedure
Percent with reduction in need for analgesic use by ≥50% at 3 months.
Measured: From enrollment to 3 months post procedure
Adverse events at 24 hours and 3 months post-procedure.
Measured: From enrolllment to 3 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Mar 2025
- Primary completion10 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Katz, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061847
- Sponsor's protocol ID
- IRB #: 24-0279
- Status last verified
- May 2026
- First submitted
- 1 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
- ClinicalTrials.gov ID
- NCT07061847
- Acronym / sponsor ID
- IRB #: 24-0279
- Conditions
- Migraine
- Keywords
- migraine, headache, intervention, lidocaine, endovascular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Given the current literature and using intent-to-treat clinical judgement, the research team believes that the treatment offered in this study may offer a promising benefit to treatment resistant migraine patients. Despite modest advances in drug therapy, some patients still suffer from chronic migraines. Therefore, the headache medicine community continues to search for alternative treatments in the form of research.
The research team is conducting a prospective observational study to gather data before and after this treatment is administered to determine whether there is improvement in migraine duration, intensity, and frequency.
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.
This is NOT the first time this procedure has been performed. Intra-arterial lidocaine infusion has been used safely during the treatment of other brain diseases. Infusing brain vessels with lidocaine is not new technique. The treatment offered in this study is new for the treatment of migraines. This particular treatment has been performed successfully in the small group studies that the study investigators are modeling after. The investigative neuro-interventionists have been rigorously trained for this approach and hold a minimum of double board certifications. This team is experienced in using these techniques for other brain diseases and have successfully performed this specific procedure in a select group of early patients. Collectively, the team holds over 45+ years of experience in performing neuro-endovascular procedures.
During the intra-arterial infusion of lidocaine for treatment of a subdural procedure, an incidental finding noted that patients had reduced headache intensity following this treatment.
Therefore, this technique has been re-purposed in this study to treat chronic migraine sufferers. The procedure is considered investigational because lidocaine is not yet FDA-approved for this specific use. Although several studies have demonstrated that this approach is a safe and tolerable treatment for chronic migraine, there is still insufficient evidence to incorporate it into the current day standard of care protocol.
Ultimately, the purpose of this study is to explore this approach to and determine if this treatment can induce a significant improvement in chronic migraine, intensity, duration, and frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine (drug), Procedure: Lidocaine ProcedureAll patients who meet eligilibity criteria at their baseline visit will be scheduled for the Lidocaine procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH).
- 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
Key exclusion criteria (21 listed)
- Recently started new migraine preventative treatment regimen within the past 3 months.
- Known allergy or sensitivity to lidocaine.
- Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure)
- Severe allergy/anaphylaxis to iodinated contrast dye.
- Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Lidocaine |
| Lidocaine ProcedureAll patient who meet eligibility criteria at their baseline visit will be scheduled for the Liocaine procedure. | Procedure or surgery | Lidocaine |
Primary outcome
Reduction in Monthly Migraine Headache Days
Time frame: From enrollment to post-treatment at 3 months
To observe a ≥50% reduction in monthly migraine headache days in one month post intra-arterial lidocaine infusion into the bilateral middle meningeal artery.
9 secondary outcomes
≥50% reduction in migraine headache intensity at 15 minutes, 2 hours, and 24 hours post procedure.
Time frame: 15 minutes, 2 hours, and 24 hours post-procedure.
Sustained freedom from headache pain >48hrs.
Time frame: >48hrs post treatment
Percentage of patients achieving ≥75% and 100% reduction in monthly headache days at 1 month and 3 months
Time frame: At 1 month and 3 month post procedure
Mean number of monthly migraine headaches days at 1 month and 3 months.
Time frame: 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
Time frame: From enrollment to 3 months post procedure
Percent with improvement in Migraine Disability Assessment (MIDAS) at 3 months from severe disability (Grade IV, score ≥21) to no moderate disability (Grade I to III, score 0-21)
Time frame: From enrollment to 3 month post procedure
Percent Headache Impact Test (HIT)-6 score <50 at 3 months.
Time frame: From enrollment to 3 months post procedure
Percent with reduction in need for analgesic use by ≥50% at 3 months.
Time frame: From enrollment to 3 months post procedure
Adverse events at 24 hours and 3 months post-procedure.
Time frame: From enrolllment to 3 months post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine (drug) and Lidocaine Procedure in people with Migraine, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Katz, MD (5163257000, jkatz2@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Monthly Migraine Headache Days (time frame: From enrollment to post-treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.