“This study constitutes the first large-scale, placebo-controlled evidence for acute relief of adolescent migraine pain and associated symptoms with an oral medication,” the authors state.
Dr. Frederick J. Derosier, with GlaxoSmithKline in Research Triangle Park, North Carolina, and colleagues point out that treatment of adolescent migraine remains a significant unmet medical need. The combination of sumatriptan and naproxen sodium is effective in adults with various types of migraine, prompting the team to test it in adolescents.
Noting the relatively high placebo response in adolescents in previous trials, the researchers first treated an acute migraine attack in 683 subjects aged 13 to 17 with a single-blind placebo. The 589 patients who did not have a response were entered in a randomized, double-blind trial.
They were assigned to treat their next migraine with either one of three doses of sumatriptan-naproxen (10/60 mg, 30/180 mg or 85/500 mg) or placebo. Rates of freedom from pain at 2 hours were similar in all three active treatment groups (29%, 27%, and 24%) and significantly higher than in the placebo group (10%; adjusted p=0.003), the investigators found.
Secondary efficacy measures were assessed with the highest dose versus placebo. In this analysis, statistically significant differences occurred for sustained pain-free status at 2 to 24 hours, and for 2-hour freedom from photophobia and phonophobia (adjusted p=0.008 for each).
All three doses of the sumatriptan-naproxen combination were well tolerated, Dr. Derosier and colleagues report.
Looking ahead, they conclude, “This efficacy evaluation, along with the pharmacokinetics and long-term safety studies, and in conjunction with regulatory review, may serve as the basis for an additional treatment option for adolescent with migraines.”