Abstract 322: Localized Injection Of Lidocaine And Glucocorticoid For Headache Treatment (LIGHT): Interim Phase 1 Study Safety Analysis

Introduction/Purpose Treatment‐refractory migraine is a challenging clinical condition. Failure to adequately control symptoms under standard therapy causes significant pain burden, migraine‐related disability, and impaired quality of life. New approaches to refractory migraine treatment may have potential to improve patient outcomes. The objective is to characterize the safety of a new endovascular approach to refractory migraine treatment. Materials/Methods A non‐randomized, open‐label phase 1 clinical trial for the injection of lidocaine (40mg) and methylprednisolone (20mg) into the middle meningeal arteries bilaterally is in progress. Patients receive the study treatment, and are evaluated at 1 week, 6 week, and 3 month follow‐up visits. Incidence of adverse events were ascertained and classified per severity and relatedness to the study treatment. An interim descriptive analysis was conducted on patients enrolled to date on the incidence of safety events. Results Of the 8 patients enrolled thus far, 62.5% (5/8) completed 3‐month follow‐up. Most patients were able to be discharged within less than 1 day of treatment. During the study duration, a total of 8 potential adverse events were ascertained; 3 (37.5%) events were unrelated to the study treatment or migraines, and 3 (3.75%) events were recurrence of migraine symptoms. Of the two adverse events possibly related to the study intervention; one patient had self‐resolving mild dizziness and blurry vision after the procedure, and one patient had temporary facial paralysis, presenting as a facial droop, lasting less than 1 hour after the procedure. The temporary facial droop was hypothesized to have occurred due to injection of lidocaine very proximally in this patient, which may have caused reflux and migration of lidocaine to branches supplying the trigeminal ganglion, resulting in a transient trigeminal nerve palsy. There were no strokes, access site issues, or mortalities in any enrolled patients. Conclusion Our interim safety analysis demonstrates favorable tolerability and safety of this investigational treatment. Endovascular injection of lidocaine and methylprednisolone demonstrates potential to be a safe approach to refractory migraine treatments. Additional data following completion of enrollment is necessary to ascertain the full safety profile of this treatment.