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From the Hospital for Children and Adolescents (Drs. Ahonen, Hämäläinen, and Hoppu) and Department of Clinical Pharmacology (Drs. Ahonen and Hoppu), University of Helsinki, and Department of Pediatrics (Dr. Rantala), University of Oulu, Finland.
Address correspondence and reprint requests to Dr. K. Ahonen, Department of Clinical Pharmacology, Haartmaninkatu 4, FIN-00290 Helsinki, Finland; e-mail: Kati.Ahonen{at}hus.fi
Objective: To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents.
Methods: A double-blind, placebo-controlled, two-way crossover trial was conducted in three hospital outpatient departments, with 8 to 17 year olds diagnosed with migraine serving as subjects (International Headache Society 1988). A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks. The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of 
40 kg. The primary efficacy endpoint was headache relief by two grades on a 5-grade face scale at 2 hours.
Results: Eighty-three patients used both treatments and 11 only the first. At 2 hours, the primary endpoint was reached nearly twice as often after sumatriptan (n = 53/83; 64%) as after placebo (n = 32/83; 39%) (p = 0.003). Already at 1 hour, headache relief was seen more often after sumatriptan (n = 42/83; 51%) than after placebo (n = 24/83; 29%) (p = 0.014). The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses (n = 94). Other endpoints, including child’s preference and using rescue medication, also favored sumatriptan. The most common adverse effect was a bad taste after sumatriptan, reported in 29% (n = 26/90) of the attacks. No serious adverse effects were observed.
Conclusion: Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age.
Received October 29, 2002. Accepted in final form December 1, 2003.
Study drugs were provided by GlaxoSmithKline.
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