A double-blind, randomized, parallel-group trial of almotriptan 12.5 mg vs. placebo in migraine patients who respond poorly to sumatriptan 50 mg

OBJECTIVE: To investigate the efficacy and tolerability of almotriptan 12.5 mg in migraine patients who respond poorly to sumatriptan 50 mg. METHODS: Patients meeting International Headache Society criteria for migraine and experiencing an unsatisfactory response to sumatriptan (at least twice) were treated first with an oral dose of sumatriptan 50 mg. Patients who did not achieve 2-h pain relief were then randomized to double-blind treatment with almotriptan 12.5 mg or placebo.RESULTS: In the first attack, 73% of the 302 participants did not respond to sumatriptan 50 mg. Of the 198 sumatriptan non-responders randomized to treatment with almotriptan 12.5 mg (n = 99) or placebo (n = 99), 70% had severe headache at baseline. Two-hour pain relief rates were significantly higher with almotriptan compared with placebo (47.5% vs.23.2%; P < 0.001). A significant treatment effect for almotriptan was also seen in pain-free rates at 2 h (33.3% vs. 14.1%;P < 0.005), complete freedom from pain and associated symptoms at 2 h (17.1% vs. 4.4%; P < 0.01) and sustained pain-free rates (20.9% vs. 9.0%; P < 0.05). The incidence of adverse events was as follows: 16.2% following treatment with sumatriptan 50 mg in the first attack; 6.5% for almotriptan 12.5 mg and 4.4% for placebo (almotriptan not statistically different from placebo) following treatment of the second attack. CONCLUSIONS: Almotriptan is an effective alternative for patients who respond poorly to sumatriptan and is associated with a placebo-like adverse event profile.