NARATRIPTAN IS EFFECTIVE AND WELL TOLERATED IN THE ACUTE TREATMENT OFMIGRAINE - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY

Objective.-To evaluate, the efficacy and tolerability of naratriptan, a novel 5-HT1 agonist in the acute treatment of migraine. Design/Metho ds.-Six hundred thirteen migraineurs, diagnosed according to Internati onal 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 co nducted at 54 United States centers. At dosing and at predetermined in tervals beginning 30 minutes postdose, patients recorded migraine pain severity, clinical disability, and presence of associated migraine sy mptoms. Safety measures included adverse events, physical examinations , vital signs, ECGs, and clinical laboratory tests. Results.-Headache relief (moderate or severs 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 nar atriptan 1 mg, 0.25 mg, 0.1 mg, and placebo, respectively (P<0.05 nara triptan 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%, 47%, 48%, and 48% of patients receiving naratri ptan 1 mg, 0.25 mg, 0.1 mg, or placebo, respectively (P<0.05 naratript an 2.5 mg and 1 mg versus placebo, 1 mg versus 0.1 mg, and 2.5 mg vers us 0.1 mg and 0.25 mg). Four hour efficacy for absence of nausea, phot ophobia, and phonophobia was similar to efficacy for headache relief a t each dose. the adverse event profile of each dose of naratriptan was similar to that of placebo. No clinically relevant change in any safe ty measure was reported. Conclusions.-Naratriptan is effective and wel l tolerated for the acute treatment of migraine. The 2.5-mg dose appea rs to offer the optimum ratio of efficacy to tolerability.