A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache

Summary

The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.

Timeline

Start

2004-11

Primary completion

—

Completion

2005-06

Outcome

Met primary endpoint

paper Almotriptan treatment, compared to placebo, resulted in a significantly greater proportion of patients achieving 2-hour pain free (37.0% vs 23.9%, P= .010) PMID 17300358 ↗

Publications

• Results Mathew NT, Finlayson G, Smith TR, Cady RK, Adelman J, Mao L, Wright P, Greenberg SJ; AEGIS Investigator Study Group. Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). Headache. 2007 Feb;47(2):189-98. doi: 10.1111/j.1526-4610.2006.00686.x.

Drugs

Indications