title: BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study.
abstract: 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.
  
  
  CONCLUSIONS
  Efficacy of BI 44370 TA was shown in a dose-dependent manner in the treatment of acute migraine attacks.
authors.affiliation: Department of Neurology and Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstrasse 55, Essen, Germany. hans.diener@uni-duisburg-essen.de
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Piero
authors.initials: P
authors.lastname: Barbanti
authors.forename: Carl
authors.initials: C
authors.lastname: Dahlöf
authors.forename: Uwe
authors.initials: U
authors.lastname: Reuter
authors.forename: Julia
authors.initials: J
authors.lastname: Habeck
authors.forename: Jana
authors.initials: J
authors.lastname: Podhorna
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage*; D015740:Calcitonin Gene-Related Peptide / Q000037:antagonists & inhibitors*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D011759:Pyrrolidines / Q000627:therapeutic use; D014363:Tryptamines / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000700:Analgesics; D011759:Pyrrolidines; D014363:Tryptamines; C115647:eletriptan; D015740:Calcitonin Gene-Related Peptide