Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: A randomized study

ObjectiveProbable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura.MethodsPatients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n = 222 intent-to-treat (ITT)) or placebo (n = 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study.ResultsSumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, p < 0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, p < 0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response fou...