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From The New England Center for Headache (Dr. Rapoport), Stamford, CT; the Headache Center, Henry Ford Hospital (Dr. Ramadan), Detroit, MI; the Adelman Headache Center (Dr. Adelman), Greensboro, NC; the Houston Headache Clinic (Dr. Matthew), Houston, TX; the Elkind Headache Center (Dr. Elkind), Mt. Vernon, NY; the California Medical Clinic for Headache (Dr. Kudrow), Encino, CA; and the Neurological Disorders Clinic, Duke University Medical Center (Dr. Earl), Durham, NC.
Address correspondence and reprint requests to Dr Ramadan, University of Cincinnati, Department of Neurology, Cincinnati Headache Center, 4010 Medical Sciences Building (ML 0525), 231 Bethesda Avenue, Cincinnati, OH 45267-0525.
This study investigated the efficacy of zolmitriptan (Zomig, formerly 311C90) in acute migraine therapy. Patients with a history of migraine were randomized in a double-blind, multicenter, placebo-controlled, dose range-finding study of oral zolmitriptan 1, 2.5, 5, or 10 mg versus placebo for the treatment of a severe or moderate migraine headache. Patients with persistent or recurrent headache 4 to 24 hours after the initial dose, who did not take escape medication, were eligible to receive a second blinded dose of either zolmitriptan or placebo. Of 1,144 patients treated, 999 evaluable patients completed the study. The headache response rates with zolmitriptan doses 
2.5 mg were 44 to 51% at 1 hour, 65 to 67% at 2 hours, and 75 to 78% at 4 hours (all significantly superior to placebo). Also, zolmitriptan 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 medication were lower with zolmitriptan doses 2.5 mg than with placebo. In patients with persistent or recurrent headache, a second zolmitriptan dose effectively treated both headache and nonheadache symptoms. Zolmitriptan was well tolerated, with a lower incidence of adverse events being reported with doses
2.5 mg than with those 5 mg. Zolmitriptan is a well tolerated and effective acute migraine therapy providing rapid relief of migraine headache within 1 hour. A clear dose-response relationship between efficacy and tolerability suggests that 2.5 mg is the optimal initial dose for the acute treatment of a migraine attack.
*Zomig is a trademark of the Zeneca Group of Companies.
See the Appendix on page 1217 for a list of participating investigators.
Supported by Glaxo Wellcome. This study was completed before the acquisition of zolmitriptan (Zomig, 311C90) by Zeneca. Zeneca now owns zolmitriptan and is responsible for the worldwide development and marketing of zolmitriptan.
Received May 8, 1997. Accepted in final form August 7, 1997.
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