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Rizatriptan Offers Children Effective, Well-Tolerated, Migraine Relief
Oral rizatriptan (Maxalt, Merck) is a highly effective and well-tolerated treatment for migraine attacks in children and adolescents, a new study suggests.
In a double-blind, placebo-controlled, 3-way crossover trial, rizatriptan at both 5-mg and 10-mg doses was found to be superior to placebo in a group of children age 6 to 17 years with a diagnosis of migraine.
"Rizatriptan is highly effective in treatment of migraine attacks in children and adolescents. Response rate of headache relief was comparable to those seen in adults and of the same magnitude as reported in 2 previous placebo-controlled studies in adolescents," the authors write.
The study, with first author Kati Ahonen, MD, from the University of Helsinki, Finland, is published online August 30 in Neurology.
End Points
According to the authors, the aim of the study was to find an effective and safe orally administered triptan suitable for use in children and adolescents.
For the study, conducted at 2 pediatric outpatient clinics at 2 hospitals in Finland, the investigators enrolled patients between January 2001 and November 2003. The trial ended in February 2004. A total of 96 subjects were included in the final analysis.
The study's primary end point was headache relief from severe or moderate headache to at least 2 grades lower on a 5-point face scale 2 hours after medication.
Secondary end points were 2 grades of relief at 1, 3, and 4 hours after treatment, complete headache relief at 1, 2, 3, and 4 hours, the child's preference of treatments, and the use of rescue medication. If rescue medication was used, the study treatment was considered a failure.
All children had a previous diagnosis of migraine, with or without aura, had experienced at least 2 migraine attacks per month lasting 4 hours or more, and had unsatisfactory previous migraine therapy with acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, all study subjects were between 6 and 17 years old and weighed 20 kg or more.