Introduction/Purpose Refractory migraine causes significant burden of pain and impaired quality of life. New endovascular approaches to therapy may potentially aid refractory migraine patients. Early cohort experiences with intra‐arterial intracranial lidocaine and steroid infusions used in other procedures (such as embolization) have suggested potential utility in exploring its application in the refractory migraine population. The objective of this completed phase 1 clinical trial was to assess safety of this new endovascular treatment for refractory migraine. Materials and Methods A non‐randomized, open‐label phase 1 clinical trial (NCT06462781) was conducted at a single site. Refractory migraine patients, defined as having inadequate symptom relief with 4 adequate trials of migraine therapy, were screened and treated with lidocaine (40mg) and methylpredisolone (20mg) infused into the middle meningeal arteries bilaterally. Patients were monitored over 3‐months to assess frequency of adverse events associated with the investigational treatment. Results Of 10 consented subjects, 9 received treatment. During 3‐month follow‐up, two non‐serious adverse events were possibly related to the intervention. One patient had post‐procedural dizziness and transient blurry vision, which both self‐resolved within hours without additional intervention. Another patient had intraprocedural partial facial droop within a few minutes of lidocaine infusion into the middle meningeal artery ipsilaterally. This adverse event resolved within 1 hour without additional treatment; it was likely caused by proximal reflux of lidocaine to the petrosal branch, causing a transient facial palsy. No significant strokes, neurological events, or mortality related to the study treatment occurred. Conclusion Intra‐arterial lidocaine and steroid were safe in this phase 1 clinical trial. Future clinical trial phases are required to ascertain efficacy of this intervention for refractory migraine treatment.
Ballout et al. (Sat,) studied this question.