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

被引:182
作者
Diener, Hans-Christoph [1 ]
Barbanti, Piero [2 ]
Dahloef, Carl [3 ]
Reuter, Uwe [4 ]
Habeck, Julia [5 ]
Podhorna, Jana [5 ]
机构
[1] Univ Duisburg Essen, Univ Hosp Essen, Dept Neurol, D-45147 Essen, Germany
[2] Hosp IRCCS San Raffaele, Milan, Italy
[3] Gothenburg Migraine Clin AB, Gothenburg, Sweden
[4] Charite, Berlin, Germany
[5] Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
关键词
Migraine; attacks; acute treatment; CGRP-antagonist; phase II study; GENE-RELATED PEPTIDE; RECEPTOR ANTAGONIST; TRIPTANS SEROTONIN; 5-HT1B/1D AGONISTS; CONTROLLED-TRIAL; SUMATRIPTAN; ELETRIPTAN; METAANALYSIS; DISEASE;
D O I
10.1177/0333102410388435
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
引用
收藏
页码:573 / 584
页数:12
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