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The tolerability and efficacy of naproxen sodium and of ergotamine tartrate plus caffeine (ergotamine) were compared in the treatment of acute migraine attacks and associated symptoms. In this multicenter, double-blind, parallel study of up to six headaches over a 3-month period, patients took naproxen sodium 825 mg, ergotamine 2 mg, or placebo at the time of the first symptom of an attack; 30 minutes later, if necessary, patients repeated naproxen sodium 275 mg, ergotamine 1 mg or placebo, as appropriate. Rescue medication was allowed 30 minutes following the second dose if needed. Active drugs provided notably better relief of head pain than did placebo; 1 hour following the first dose the difference between naproxen sodium and placebo was statistically significant. Naproxen sodium was as efficacious as ergotamine in the relief of migraine attacks and associated symptoms. Relief of vomiting, nausea, photophobia, and motor symptoms favored naproxen sodium over ergotamine; these differences were statistically significant for nausea and motor symptoms. Ergotamine-treated patients reported more complaints and had more severe and longer-lasting complaints than patients on the other two regimens. Overall tolerance ratings by both investigators and patients indicated that naproxen sodium and placebo were tolerated significantly better than ergotamine.

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SYNOPSIS In this multicenter, double‐blind, parallel study, patients with muscle contraction headache were randomized to treatment with either two naproxen sodium 275 mg capsules per headache or matching placebo. Of a total of 161 patients enrolled, 137 received trial medication and 134 (63 taking naproxen sodium and 71 taking placebo) were valid for efficacy analysis. During four headache episodes, patients recorded, on a visual analog scale, pain intensity just before the dose of trial medication (baseline) and at1, 2, and 4 hours after this dose. For each patient, two additional indices were derived from these data: Pain Intensity Difference (PID), the difference between intensity of pain at baseline and intensity of pain recorded at any time after treatment began; and Summed Pain Intensity Difference (SPID), the sum of the PIDs at a given hour. Results significantly favored naproxen sodium over placebo (p<0.05) at all times. Naproxen sodium was found to be well tolerated and was more efficacious than placebo in the treatment of muscle contraction headache.

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