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NEUROLOGY 1997;49:1219-1225
© 1997 American Academy of Neurology

Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine

G. D. Solomon, MD, R. K. Cady, MD, J. A. Klapper, MD, N. L. Earl, MD, J. R. Saper, MD, N. M. Ramadan, MD and The 042 Clinical Trial Study Group*

From the Cleveland Clinic Foundation (Dr. Solomon), Cleveland, OH; the Headache Care Center (Dr. Cady), Springfield, MO; the colorado Neurology and Headache Center (Dr. Klapper), Denver, CO; the Duke University Medical Center, Durham, and Glaxo Wellcome Inc (Dr. Earl), Research Triangle Park, NC; the Michigan Head-Pain and Neurological Institute (Dr. Saper), Ann Arbor, MI; and the Headache Center (Dr. Ramadan), Henry Ford Hospital, Detroit, MI.

Address all correspondence and reprint requests to Dr. Nabih M. Ramadan, Director, Cincinnati Headache Center, University of Cincinnati, Department of Neurology, 231 Bethesda Avenue (ML 0525), Cincinnati, OH 45267-0525.

Previous studies demonstrated that zolmitriptan at doses of 1 to 25 mg was highly effective in treating acute migraine attacks. The 2.5-mg dose had a favorable therapeutic effect with high efficacy and good tolerability. The objective of this study was to further evaluate the efficacy of a single 2.5-mg dose of zolmitriptan (Zomig, formerly known as 311C90) for acute treatment of a single moderate or severe migraine attack. The study was a randomized, double-blind, placebo-controlled clinical trial. Female and male patients, 12 to 65 years old, with migraine (with or without aura) for ≥1 year, one to six migraines per month, and age at onset < 50 years were included; 327 patients were screened and randomized to receive either zolmitriptan (n = 219) or placebo (n = 108). Patients treated a single moderate or severe migraine headache with 2.5 mg zolmitriptan or placebo and recorded clinical efficacy and adverse events on a diary form. Headache response at 2 hours was 62% for zolmitripan compared with 36% for placebo(p < 0.001); at 4 hours, headche response was 70% with zolmitriptan and 37% with placebo (p < 0.001). Headache recurrence in patients treated with 2.5 mg zolmitriptan was 22% (versus placebo 30%). The headache response at 4 hours, pain-free rate, and response rate of nonheadache symptoms favored zolmitriptan over placebo. No serious adverse events were associated with zolmitriptan treatment. A 2.5-mg dose of zolmitriptan is clinically effective and well tolerated for the acute treatment of migraine.


*See the Appendix on page 1224 for a list of participating investigators.

Supported by Glaxo Wellcome. This study was completed before the acquisition of zolmitriptan by Zeneca. Zeneca now owns zolmitriptan and is responsible for the worldwide development and marketing of zolmitriptan.

Received May 7, 1997. Accepted in final form August 6, 1997.




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