A randomized trial of rizatriptan in migraine attacks in children

Objective: To examine the efficacy of rizatriptan and the consistency of treatment response in migraine attacks of children and adolescents. Methods: We conducted a double-blind, placebo-controlled three-way crossover trial in patients ages 6 to 17 years diagnosed with migraine in two pediatric hospital outpatient clinics. Two doses of rizatriptan and a matching placebo were administered at home during three attacks. Rizatriptan dose was 5 mg for those with a body weight of 20 to 39 kg, and 10 mg for those with a body weight of 40 kg or more. The primary efficacy endpoint was headache relief by two grades on a five-grade face scale at 2 hours. Results: Ninety-six patients used all three treatments, 10 used two, and 10 only the first. At 2 hours, the primary endpoint was reached twice as often after both treatments of rizatriptan (first 74%, n = 71/96; second 73%, n = 70/96) as after placebo (36%, n = 35/96) (p < 0.001). Already at 1 hour, rizatriptan was clearly more effective as headache relief was reported by 50% (n = 48/96) and 55% (n = 53/96) of children after the first and the second dose of rizatriptan, compared to 29% (n = 28/96) after placebo (p = 0.004). Rizatriptan was superior at 3 and 4 hours, and the other endpoints also favored rizatriptan. Efficacy of rizatriptan was constant over the two treated attacks, and the findings were similar in children using the dose of 5 and 10 mg. No serious adverse effects were observed. Conclusions: Oral rizatriptan is effective and well-tolerated for migraine attacks in children over age 6 years.