A two-drug combination that relieves migraines in adults also works well in adolescents, new research indicates.
Because the combination of Imitrex (sumatriptan see structure left) and naproxen (structure right) sodium (Aleve and other brand names) isn't approved for use by the U.S. Food and Drug Administration for this age group, doctors must prescribe it "off label" to adolescents.
"There are no FDA-approved abortive [migraine] treatments for children," said Dr. Noah Rosen, director of the Headache Center at the Cushing Neuroscience Institute in Great Neck, N.Y. "This is the first really large-scale abortive treatment study for adolescents."
Migraines in children and adolescents are physiologically no different from migraines in adults, said Drexler, although migraines in younger people tend not to last as long.
The class of drugs known as triptans are the most studied, but none of those trials have shown a great benefit, possibly because of a large placebo response, the study authors wrote.
For this study, the authors randomly assigned almost 600 teens and preteens 12 to 17 years old to either a placebo or one of three doses of the sumatriptan/naproxen combination over a period of 12 weeks.
The doses were 10 milligrams (mg) sumatriptan and 60 mg naproxen, 30/180 mg and 85/500 mg, respectively.
Between 23 percent and 29 percent of those who took one of the doses of sumatriptan/naproxen reported being pain-free within two hours of taking the drug, vs. 10 percent in the placebo group...
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