OPTIMIZING THE DOSE OF ZOLMITRIPTAN (ZOMIG,ASTERISK 311C90) FOR THE ACUTE TREATMENT OF MIGRAINE - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGE-FINDING STUDY

This study investigated the efficacy of zolnitriptan (Zomig, formerly 311C90) in acute migraine therapy. Patients with a history of migraine were randomized in a double-blind, multicenter, placebo-controlled, d ose range-finding study of oral zolmitriptan 1, 2.5, 5, or 10 mg versu s placebo for the treatment of a severe or moderate migraine headache. Patients with persistent or recurrent headache 4 to 24 hours after th e initial dose, who did not take escape medication, were eligible to r eceive a second blinded dose of either zolmitriptan or placebo. Of 1,1 44 patients treated, 999 evaluable patients completed tl-le study. The headache response rates with zolmitriptan doses greater than or equal to 2.5 mg were 44 to 51% at 1 hour, 65 to 67% at 2 hours, and 75 to 7 8% at 4 hours (all significantly superior to placebo). Also, zolmitrip tan effectively relieved migraine-associated symptoms such as nausea, photophobia and phonophobia, and reduced activity impairment. Rates of headache recurrence, headache persistence, and use of escape medicati on were lower with zolmitriptan doses greater than or equal to 2.5 mg than with placebo. In patients with persistent or recurrent headache, a second zolmitriptan dose effectively treated both headache and nonhe adache symptoms. Zolmitriptan was well tolerated, with a lower inciden ce of adverse events being reported with doses less than or equal to 2 .5 mg than with those greater than or equal to 5 mg. Zolmitriptan is a well tolerated and effective acute migraine therapy providing rapid r elief of migraine headache within 1 hour. A clear dose-response relati onship between efficacy and tolerability suggests that 2.5 mg is the o ptimal initial dose for the acute treatment of a migraine attack.