Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial
Daniel A Tonetti, MD
Summary
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or above * Referred for diagnostic angiography * Diagnosis of intractable migraine * Written informed consent able to be obtained from subject Exclusion Criteria: * Baseline HIT-6 score less than 60 (severe) * Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data * Concomitant intracranial pathology (eg, intracranial malignancy) * Known hypersensitivity and/or cont…
Interventions
- DrugLidocaine (drug)
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
- DrugSaline
Intra-arterial saline infusion into bilateral middle meningeal arteries
Location
- Cooper University Health CareCamden, New Jersey