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Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

RecruitingPhase 2NCT07061847
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
Conditions
Interventions
  • Drug: Lidocaine (drug)
  • Procedure: Lidocaine Procedure
Sponsor
Northwell Health
Start date
2025-03-10
Primary completion
2027-03-10
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 b…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07061847