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.
Ahonen
K
K
Hospital for Children and Adolescents, Department of Clinical Pharmacology, University of Helsinki, Finland.. Kati.Ahonen@fimnet.fi
Hämäläinen
M L
ML
Eerola
M
M
Hoppu
K
K
D000284:Administration, Oral; D000293:Adolescent; D000553:Ambulatory Care / Q000706:statistics & numerical data; D002648:Child; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005387:Finland / Q000453:epidemiology; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D015990:Placebo Effect; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage; D014230:Triazoles / Q000008:administration & dosage*; D014363:Tryptamines / Q000008:administration & dosage*
D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan