Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
Recruiting
Phase 2Interventional Study
Migraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Northwell Health · Other
Who this trial is looking for
This trial is looking for adults with severe chronic migraines that don't improve with standard treatments. Participants will receive a targeted lidocaine treatment to help reduce headache pain and frequency.
Are You a Good Fit for This Trial?
Rules you outChronic subdural hematomaSymptomatic peripheral arterial diseaseActive chronic pain syndromesMajor psychiatric disorder with significant depression
You may be able to join if
I am aged between 18 and 75 years old.
I have very severe migraines at least 15 days a month for over 3 months.
I have not found relief from at least 3 migraine preventive treatments.
I score 6 or 7 on a migraine severity scale.
I experience moderate to severe headache pain more than half the time.
I have been diagnosed with chronic daily headache for at least 12 months.
I report inadequate response to my current migraine treatment.
I have been on stable medications for the last 3 months.
You may not be able to join if
I have started a new migraine preventative treatment in the last 3 months.
I am allergic to lidocaine.
I have had a severe allergy to iodinated contrast dye.
I have any significant brain condition recently shown on brain imaging.
I have had a stroke or heart attack in the past 3 months.
I have a history of severe kidney problems.
I have had abnormal heart test results in the past 3 months.
I am pregnant or planning a pregnancy during the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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. Med…
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.
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