Cinnarizine vs. topiramate for migraine prophylaxis in children: a randomized, double-blind, parallel-group clinical trial

OBJECTIVES: Migraine is a common and disabling neurological disorder in children, often requiring preventive treatment. This study aimed to compare the efficacy and tolerability of cinnarizine and topiramate in the prophylaxis of migraine in children and adolescents. MATERIALS AND METHODS: In this randomized, double-blind, parallel-group clinical trial, 96 children aged 6-15 years with a diagnosis of migraine according to the International Classification of Headache Disorders (ICHD-3) [1], including both migraine with and without aura, without restriction to specific subtypes were enrolled. Participants were randomly assigned to receive either cinnarizine (25 mg once daily) or topiramate (25 mg once daily) for 12 weeks. Migraine attack frequency and severity were recorded using headache diaries at baseline, one month, and three months after treatment initiation. The primary outcome was the change in monthly migraine attack frequency. Secondary outcomes included changes in headache severity and the occurrence of adverse events. Between-group comparisons were performed using the Mann-Whitney U test, and within-group changes over time were analyzed using the Friedman test. RESULTS: Both cinnarizine and topiramate significantly reduced monthly migraine attack frequency and headache severity over the 12-week treatment period (P < 0.001 for within-group comparisons). At three months, the median number of migraine attacks decreased to two attacks per month in both groups, with no statistically significant difference observed between the two treatments (P = 0.81). Headache severity scores also improved significantly in both groups, and no between-group differences were observed at follow-up (P = 0.74). Both medications were generally well tolerated, with no statistically significant differences in the incidence of adverse events between groups. Appetite reduction was reported in 4.2% of the cinnarizine group versus 14.6% of the topiramate group. While a numerically lower incidence of appetite reduction was observed in the cinnarizine group (4.2% vs. 14.6%), this difference was not statistically significant (P = 0.159, Fisher's exact test; OR = 0.255, 95% CI: 0.05-1.27). CONCLUSION: Both cinnarizine and topiramate significantly reduced the frequency and severity of migraine attacks in children. No statistically significant difference in efficacy was detected between the two treatments. A numerically lower incidence of appetite reduction was observed with cinnarizine, although this difference was not statistically significant. Larger studies are needed to evaluate potential differences in tolerability. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT) IRCT20221108056444N1. Registered 12 February 2023 Retrospectively registered, https://www.en.irct.ir/trial/66774.