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Randomized Controlled Trial
. 2008 Jul 8;71(2):114-21.
doi: 10.1212/01.wnl.0000316800.22949.20.

Multimechanistic (Sumatriptan-Naproxen) Early Intervention for the Acute Treatment of Migraine

Randomized Controlled Trial

Multimechanistic (Sumatriptan-Naproxen) Early Intervention for the Acute Treatment of Migraine

S D Silberstein et al. Neurology. .

Erratum in

  • Neurology. 2009 Apr 14;72(15):1369.. Toso, Cynthia [added]


Background: Research suggests treating a migraine at the first sign of pain increases the likelihood of the best clinical outcome.

Objective: To investigate the efficacy and tolerability of a fixed-dose, single-tablet formulation of sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg (sumatriptan/naproxen) as early intervention acute therapy for migraine.

Methods: Patients (aged 18 to 65 years) with International Headache Society-defined migraine with or without aura were enrolled in one of two identically designed, randomized, double-blind, parallel group, placebo-controlled studies. Patients treated a single migraine within 1 hour of onset of migraine head pain and while the pain was mild with either sumatriptan/naproxen or placebo. The primary efficacy measure was the percentage of patients who became pain-free 2 hours postdose.

Results: Intent-to-treat analyses consisted of 576 and 535 migraineurs. At 2 hours, 52% and 51% of sumatriptan/naproxen-treated patients were pain free, as compared to 17% and 15% of placebo-treated patients (p < 0.001). Significant pain-free responses in favor of sumatriptan/naproxen were demonstrated as early as 30 minutes, maintained at 1 hour, and sustained from 2 to 24 hours. At 2 and 4 hours, sumatriptan/naproxen provided significantly lower rates of traditional migraine-associated symptoms (nausea, photophobia, and phonophobia) and nontraditional migraine-associated symptoms (neck pain/discomfort and sinus pain/pressure). The most commonly reported adverse events were nausea (< or =4%) and dizziness (< or =2%).

Conclusion: The fixed-dose single-tablet formulation of sumatriptan/naproxen was effective and well tolerated in an early intervention paradigm for the acute treatment of migraine, including traditional and nontraditional symptoms.

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