Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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 duration.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• 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

Locations
United States
New York
Neuroscience Institute at Great Neck
RECRUITING
Great Neck
Contact Information
Primary
Jeffrey Katz, MD
jkatz2@northwell.edu
5163257000
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 40
Treatments
Experimental: Lidocaine
All patients who meet eligilibity criteria at their baseline visit will be scheduled for the Lidocaine procedure.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov