CLINICAL EFFICACY AND TOLERABILITY OF 2.5 MG ZOLMITRIPTAN FOR THE ACUTE TREATMENT OF MIGRAINE

Previous studies demonstrated that zolmitriptan at doses of 1 to 25 mg was highly effective in treating acute migraine attacks. The 2.5-mg d ose had a favorable therapeutic effect with high efficacy and good tol erability. The objective of this study was to further evaluate the eff icacy of a single 2.5-mg dose of zolmitriptan (Zomig, formerly known a s 311C90) for acute treatment of a single moderate or severe migraine attack. The study was a randomized, double-blind, placebo-controlled c linical trial. Female and male patients, 12 to 65 years old, with migr aine (with or without aura) for greater than or equal to 1 year, one t o six migraines per month, and age at onset < 50 years were included; 327 patients were screened and randomized to receive either zolmitript an (n = 219) or placebo (n = 108). Patients treated a single moderate or severe migraine headache with 2.5 mg zolmitriptan or placebo and re corded clinical efficacy and adverse events on a diary form. Headache response at 2 hours was 62% for zolmitriptan compared with 36% for pla cebo (p < 0.001); at 4 hours, headache response was 70% with zolmitrip tan and 37% with placebo (p < 0.001). Headache recurrence in patients treated with 2.5 mg zolmitriptan was 22% (versus placebo 30%). The hea dache response at 4 hours, pain-free rate, and response rate of nonhea dache symptoms favored zolmitriptan over placebo. No serious adverse e vents were associated with zolmitriptan treatment. A 2.5-mg dose of zo lmitriptan is clinically effective and well tolerated for the acute tr eatment of migraine.