Sumatriptan formulated with RT technology™ as early intervention for migraine in adolescents

Abstract

To assess the feasibility, efficacy, and tolerability of early intervention with sumatriptan tablets formulated with RT Technology™ (sumatriptan RT) for adolescent migraine. Conventional triptan tablets, a treatment of choice for migraine in adults, have not been demonstrated reliably effective in adolescents in prospective, placebo-controlled studies. Neither the early-intervention approach nor sumatriptan RT, a fast-disintegrating/rapid-release oral tablet, has previously been studied in adolescent migraineurs. Males or females 12 to 17-year-old diagnosed with migraine with or without aura were asked to treat four migraine attacks over a 6 mo period with sumatriptan RT 100 mg as early intervention (i.e., administered within 30 min of attack onset while pain was still mild). Of the 35 patients who enrolled, 32 treated at least one migraine attack, and 23 treated all four-migraine attacks. Pain-free response 2 hr postdose (primary endpoint) was reported in 71% of the 112 attacks treated. Migraine-free response (i.e., no pain; no nausea, vomiting, photophobia, or phonophobia; and no use of rescue medication) 2 hr postdose was reported in 69% of attacks. Response rates were consistent from attack to attack. Rescue medication was used in 19% of migraine attacks. In 112 attacks, a total of 25 adverse events (none serious) were reported in nine patients. The most common adverse events were worsening of symptoms (n = 5), neck pain (n = 4), and chest tightening (n = 4). Early intervention with sumatriptan RT constitutes a promising approach to treating migraine in adolescents and warrants further assessment in controlled clinical trials.

Keywords

Headache - migraine - adolescent - sumatriptan - triptan