Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment

Part of paid clinical trials in Camden, New Jersey.

Sponsor
Daniel A Tonetti, MD
Study ID
NCT07361549
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Headache
  • Refractory Migraine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine (drug) — DRUG
    Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
  • Saline — DRUG
    Intra-arterial saline infusion into bilateral middle meningeal arteries

Study Details

The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)

Key Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Intra-arterial lidocaine
  • Sham Comparator: Sham
    Intra-arterial saline

Primary Outcome Measure

Change in Headache Impact Test-6 Scores [ Time Frame: From baseline to 4 week follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University Health CareCamdenNew Jersey08103
Cooper University Health Care

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Cooper University Health Care· Camden, NJ

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