A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents

Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. Other studies have shown that almotriptan is effective and well tolerated in adults. Migraines in teenagers/adolescents are very similar to migraines in adults, except that the duration is usually less in adolescents (they last 1 to 24 hours in adolescents). This study will evaluate the usefulness of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. This is a randomized, double-blind, parallel-group, and placebo-controlled study. During a 30-day run-in period, patients will treat their migraines as they normally would. During this time, the frequency and severity of headaches will be recorded. At the second visit, patients will be randomized (like with the toss of a coin) to a treatment group to receive one oral dose of almotriptan malate (AXERT®) 6.25, 12.5, or 25 milligrams or placebo. Approximately the same number of patients will be assigned to each of the four treatment groups. Patients will take this one-time dose when the next migraine of at least moderate severity occurs. Patients will record assessments in a diary for up to 24 hours after the study drug is given to help determine the drug's effect on headache pain intensity. Patients will return for a third visit within 2 to 14 days from taking the study medication. A physical examination, electrocardiogram (a painless test of the heart), and laboratory tests will be performed at the first and third visits. The objective of this study is to determine the effectiveness and tolerability of 3 dosage strengths of almotriptan malate (AXERT®) in adolescents with migraine headaches. Almotriptan oral tablets, 6.25, 12.5, or 25 milligrams, or placebo