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

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 subject...

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Bibliographic Details
Published in:Cephalalgia 2011-04, Vol.31 (5), p.573-584
Main Authors: Diener, Hans-Christoph, Barbanti, Piero, Dahlöf, Carl, Reuter, Uwe, Habeck, Julia, Podhorna, Jana
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Adult
Aged
Analgesics - administration & dosage
Calcitonin Gene-Related Peptide - antagonists & inhibitors
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Male
Middle Aged
Migraine Disorders - drug therapy
Pyrrolidines - therapeutic use
Tryptamines - therapeutic use
Young Adult
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Summary: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.
ISSN:0333-1024
1468-2982
DOI:10.1177/0333102410388435