Abstract

Background/Objectives: There is limited evidence supporting the use of lomerizine, a calcium channel blocker approved for migraine prophylaxis in Japan, in children. This study evaluated the prophylactic efficacy of lomerizine in a pediatric population with migraine and identified the baseline factors independently associated with treatment response. Methods: This single-center, retrospective cohort study enrolled 83 patients aged ≤18 years prescribed lomerizine for migraine prophylaxis. The primary outcome was headache improvement, defined as a ≥50% reduction in monthly headache days from baseline, assessed at 3–4 and 6–8 months. Multivariable logistic regression included prespecified comorbidity-based covariates: psychosocial factors, neurodevelopmental disorder, and postural orthostatic tachycardia syndrome. Results: Headache improvement was observed in 34 of 80 (42.5%) patients at 3–4 months, and in 36 of 71 (50.7%) patients at 6–8 months. Response rates at 3–4 months and 6–8 months, respectively, were 57.7% and 67.4% among patients without psychosocial factors and 14.3% and 20.0% among those with psychosocial factors. Psychosocial factors were the only variables independently associated with a lower probability of improvement at both time points (3–4 months: adjusted odds ratio, 0.122; 95% confidence interval, 0.036–0.419; p < 0.001; 6–8 months: adjusted odds ratio, 0.137; 95% confidence interval, 0.041–0.456; p = 0.001). Conclusions: Patients receiving lomerizine experienced clinically meaningful improvement in headache frequency, particularly those without psychosocial comorbidity. Psychosocial comorbidity was the only baseline factor independently associated with a poor treatment response, underscoring the potential importance of routine psychosocial screening and a possible benefit from concurrent psychological interventions; these findings require prospective confirmation.

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