OBJECTIVE: Probable 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. METHODS:Patients treated a headache of probable migraine without aura when pain was moderate or severe withsumatriptan/naproxen sodium ( N = 222 intent-to-treat (ITT)) orplacebo ( N = 221 ITT/complete case analysis (a) ) in this randomized, double-blind, parallel-group study. RESULTS:Sumatriptan/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 four hours postdose ( P < 0.001), pain-free response maintained one to two hours postdose ( P = 0.034) and two to four hours postdose ( P < 0.001), headache relief four hours postdose ( P < 0.001), headache relief maintained two to four hours postdose ( P = 0.015), sustained headache relief two through 24 hours postdose ( P = 0.002), and rescue medication use ( P < 0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). CONCLUSION:Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.
RCT Entities:
OBJECTIVE: Probable 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. METHODS:Patients 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 analysis (a) ) in this randomized, double-blind, parallel-group study. RESULTS:Sumatriptan/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 four hours postdose ( P < 0.001), pain-free response maintained one to two hours postdose ( P = 0.034) and two to four hours postdose ( P < 0.001), headache relief four hours postdose ( P < 0.001), headache relief maintained two to four hours postdose ( P = 0.015), sustained headache relief two through 24 hours postdose ( P = 0.002), and rescue medication use ( P < 0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). CONCLUSION:Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.