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BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study.

Author(s): Diener HC, Barbanti P, Dahlof C, Reuter U, Habeck J, Podhorna J

Affiliation(s): Department of Neurology and Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstrasse 55, Essen, Germany. hans.diener@uni-duisburg-essen.de

Publication date & source: 2011-04, Cephalalgia., 31(5):573-84. Epub 2010 Dec 20.

Publication type: Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

METHODS: Four hundred and sixty-one adult subjects with migraine were randomised to one of five treatments, the oral antagonist at the calcitonin gene-related peptide (CGRP) receptor BI 44370 TA (50 mg, 200 mg, 400 mg), active comparator eletriptan 40 mg or placebo. The analysis included 341 subjects who took study medication. RESULTS: The primary endpoint, pain-free after two hours, was reached by significantly more subjects in the BI 44370 TA 400 mg (20/73 = 27.4%) and eletriptan 40 mg (24/69 = 34.8%) groups compared to placebo (6/70 = 8.6%, p = .0016), but not by subjects in the BI 44370 TA 200 mg group (14/65 = 21.5%). The effect of 50 mg BI 44370 TA (5/64 = 7.8%) was similar to that of placebo. Analysis of secondary endpoints supported the conclusion from the primary analysis. The frequency of adverse events was low in all groups. CONCLUSION: Efficacy of BI 44370 TA was shown in a dose-dependent manner in the treatment of acute migraine attacks.

Page last updated: 2011-12-09

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