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

Summary

The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. In this study, adolescents will be given a single dose of study medication to treat one migraine headache.

Timeline

Start

2003-07

Primary completion

—

Completion

2005-07

Outcome

Mixed primary results

paper The 2-hour pain-relief rate was significantly higher with almotriptan 25 mg compared with placebo (66.7% vs 55.3%; P = .022). PMID 18484981 ↗

paper for the almotriptan 25 mg and placebo groups was not significantly different. PMID 18484981 ↗

Publications

• Linder SL, Mathew NT, Cady RK, Finlayson G, Ishkanian G, Lewis DW. Efficacy and tolerability of almotriptan in adolescents: a randomized, double-blind, placebo-controlled trial. Headache. 2008 Oct;48(9):1326-36. doi: 10.1111/j.1526-4610.2008.01138.x. Epub 2008 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	almotriptan	Small molecule	6.25 mg	Oral
Subject	almotriptan	Small molecule	12.5 mg	Oral
Subject	almotriptan	Small molecule	25 mg	Oral

Indications