期刊
CEPHALALGIA
卷 31, 期 5, 页码 573-584出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/0333102410388435
关键词
Migraine; attacks; acute treatment; CGRP-antagonist; phase II study
资金
- Allergan
- Almirall
- AstraZeneca
- Bayer
- GSK
- Janssen-Cilag
- Pfizer
- German Research Council (DFG)
- German Ministry of Education and Research (BMBF)
- European Union
- Johnson Johnson
- Jerini
- MSD
- Vasopharm
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.
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