Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine. The 042 Clinical Trial Study Group.

Abstract

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 > or = 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 zolmitriptan compared with 36% for placebo (p < 0.001); at 4 hours, headache 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.

• Authors: G D Solomon, R K Cady, J A Klapper, N L Earl, J R Saper, N M Ramadan
• Journal: Neurology (Neurology) Vol. 49 Issue 5 Pg. 1219-25 (Nov 1997) ISSN: 0028-3878 [Print] United States
• PMID: 9371897 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Oxazoles
• Oxazolidinones
• Serotonin Receptor Agonists
• Tryptamines
• zolmitriptan

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Child
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Oxazoles (administration & dosage, adverse effects)
• Oxazolidinones
• Serotonin Receptor Agonists (administration & dosage, adverse effects)
• Tryptamines