Naratriptan is effective and well tolerated in the acute treatment of migraine. Results of a double-blind, placebo-controlled, parallel-group study. Naratriptan S2WA3001 Study Group

Headache
A KlassenA Laurenza

Abstract

To evaluate the efficacy and tolerability of naratriptan, a novel 5-HT1 agonist, in the acute treatment of migraine. Six hundred thirteen migraineurs, diagnosed according to International Headache Society criteria, treated a single migraine attack with naratriptan tablets (2.5 mg, 1 mg, 0.25 mg, or 0.1 mg) or placebo in a randomized, double-blind, placebo-controlled, parallel-group study conducted at 54 United States centers. At dosing and at predetermined intervals beginning 30 minutes postdose, patients recorded migraine pain severity, clinical disability, and presence of associated migraine symptoms. Safety measures included adverse events, physical examinations, vital signs, ECGs, and clinical laboratory tests. Headache relief (moderate or severe pain at dosing reduced to mild or no pain) 4 hours postdose was reported in 60% of patients receiving naratriptan 2.5 mg compared with 50%, 35%, 32%, and 34% of patients receiving naratriptan 1 mg, 0.25 mg, 0.1 mg, and placebo, respectively (P < 0.05 naratriptan 2.5 mg and 1 mg versus placebo, 1 mg versus 0.1 mg, and 2.5 mg versus 0.1 mg and 0.25 mg). Clinical disability 4 hours postdose was reported as mild or none for 70% of patients receiving naratriptan 2.5 mg compared with 63%...Continue Reading

Citations

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