Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine

David J. Hewitt*, Sheena K. Aurora, David W. Dodick, Peter J. Goadsby, Yang (Joy) Ge, Robert Bachman, Donna Taraborelli, Xiaoyin Fan, Christopher Assaid, Christopher Lines, Tony W. Ho

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

243 Citations (Scopus)

Abstract

Background: This study evaluated the CGRP receptor antagonist MK-3207 for acute treatment of migraine.Methods: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, two-stage adaptive study with two interim efficacy analyses to facilitate optimal dose selection. Migraine patients were initially randomized to MK-3207 2.5, 5, 10, 20, 50 and 100 mg or placebo to treat a moderate/severe migraine. One or more doses were to be discontinued based on the first interim analysis and a lower or higher dose could be added based on the second interim analysis. The primary endpoint was two-hour pain freedom.Results: A total of 547 patients took study medication. After the first interim analysis, the two lowest MK-3207 doses (2.5, 5 mg) were identified as showing insufficient efficacy. Per the pre-specified adaptive design decision rule, only the 2.5-mg group was discontinued and the five highest doses (5, 10, 20, 50, 100 mg) were continued into the second stage. After the second interim efficacy analysis, a 200 mg dose was added due to insufficient efficacy at the top three (20, 50, 100 mg) doses. A positive dose-response trend was demonstrated when data were combined across all MK-3207 doses for two-hour pain freedom (p < .001). The pairwise difference versus placebo for two-hour pain freedom was significant for 200 mg (p < .001) and nominally significant for 100 mg and 10 mg (p < .05). The incidence of adverse events appeared comparable between active treatment groups and placebo, and did not appear to increase with increasing dose.Conclusions: MK-3207 was effective and generally well tolerated in the acute treatment of migraine.
Original languageEnglish
Pages (from-to)712-722
Number of pages11
JournalCephalalgia
Volume31
Issue number6
DOIs
Publication statusPublished - Apr 2011

Keywords

  • CGRP
  • MK-3207
  • migraine
  • randomized trial
  • 5-HT1B/1D AGONISTS
  • TRIPTANS
  • TELCAGEPANT
  • HEADACHE
  • BLOCKADE

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