Finally, effective migraine relief for teenagers?

The combination of sumatriptan and naproxen sodium safely and effectively relieves acute adolescent migraine pain and its associated symptoms compared with placebo, according to the results of a new randomized trial.

Billed as the first large-scale, placebo-controlled evidence for acute relief of adolescent migraine pain, the trial involved approximately 600 teenagers aged 12 to 17 years who suffered an average of 2 to 8 migraines per month. The trial consisted of a 12-week, single-blind, run-in phase followed by a 12-week, double-blind, treatment phase in which patients received either placebo or 1 of 3 combinations of the active agents sumatriptan 10 mg/naproxen sodium 60 mg; sumatriptan 30 mg/naproxen 180 mg; or sumatriptan 85 mg/naproxen 500 mg.

All doses were significantly more effective compared with placebo for leaving takers pain free at 2 hours posttreatment, and no significant differences existed among doses (29%, 27%, and 24%, respectively). Patients reported fewer adverse effects with the lowest dose versus the highest; nausea-free rates at 2 hours posttreatment were no better with the highest dose than they were with placebo. Overall, little difference existed in incidence of adverse effects among the 3 regimens.

In terms of efficacy, the 85/500-mg combination provided significant sustained pain relief from 2 to 24 hours posttreatment compared with placebo (23% vs 9%). In addition, a greater percentage of teenagers who received the 85/500-mg dose compared with placebo were photophobia-free (59% vs 41%) and phonophobia-free (60% vs 42%) at 2 hours posttreatment.

The researchers concluded that all 3 doses were effective and well tolerated, but the efficacy and better tolerability at earlier time points shown by the 10/60-mg dose may make it superior for shorter-duration headaches and younger teenagers, whereas good tolerability and better efficacy at later time points may make the 85/500-mg dose superior for longer-duration and recurring migraines and older teenagers.

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