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Published online before print August 30, 2006, doi:10.1212/01.wnl.0000238179.79888.44)
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NEUROLOGY 2006;67:1135-1140
© 2006 American Academy of Neurology

A randomized trial of rizatriptan in migraine attacks in children

K. Ahonen, MD, M. L. Hämäläinen, MD, PhD, M. Eerola, PhD and K. Hoppu, MD, PhD

From the Hospital for Children and Adolescents (K.A., M.L.H., K.H.), Department of Clinical Pharmacology (K.A., K.H.), and Department of Mathematics and Statistics (M.E.), University of Helsinki, Finland.

Address correspondence and reprint requests to Dr. Kati Ahonen, Department of Clinical Pharmacology, University of Helsinki, Haartmaninkatu 4, FIN-00290 Helsinki, Finland; e-mail: Kati.Ahonen{at}fimnet.fi

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.

This article was previously published in electronic format as an Expedited E-Pub on August 30, 2006, at www.neurology.org.

Disclosure: The authors report no conflicts of interest.

Received November 29, 2005. Accepted in final form June 8, 2006.






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