The Efficacy of Triptans in Childhood and Adolescence Migraine

Abstract

Studies on the acute treatment of migraine in children and adolescents are rare and difficult to design. In particular, the high placebo response in some trials makes it difficult to prove efficacy of a verum drug. All available placebo-controlled trials on the acute migraine treatment in children and adolescents with a triptan were analyzed with respect to different end points (rate of pain free and pain relief at 2hours; rate of adverse events). We identified 6 crossover and 11 parallel group trials. Although the trials were heterogenous with respect to the triptans and the dosage, pooled data were calculated. The pooled responder rate of triptans for 2hours pain free was 36.0% in crossover trials (significant difference to placebo with 17.7%) and 32.5% in parallel group trials (significant difference to placebo with 26.3%). Triptans also showed a significantly higher pain relief rate at 2hours than placebo both in crossover and parallel group trials. The rate of adverse events was significantly higher after triptans than after placebo. However, triptans were well tolerated in all trials. At least 1 trial with significant efficacy was found for sumatriptan (10-20mg nasal spray), zolmitriptan (2.5-5mg tablet), rizatriptan (5-10mg tablet), and almotriptan (12.5-25mg tablet). Placebo rates for efficacy were considerably lower in crossover trials than in parallel group trials. This analysis suggests that parallel group trials on the acute treatment of migraine in children and adolescents with a triptan show a very low therapeutic gain because of a high placebo rate. The verum response rates, however, are very similar to those seen in adulthood trials. However, there is sufficient evidence that at least some triptans are efficacious even in childhood and adolescence.