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 Ge, Robert Bachman, Donna Taraborelli, Xiaoyin Fan, Christopher Assaid, Christopher Lines, Tony W. Ho

Research output: Contribution to journalArticle

174 Scopus citations

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 (US)
Pages (from-to)712-722
Number of pages11
JournalCephalalgia
Volume31
Issue number6
DOIs
StatePublished - Apr 1 2011

Keywords

  • CGRP
  • MK-3207
  • migraine
  • randomized trial

ASJC Scopus subject areas

  • Clinical Neurology

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    Hewitt, D. J., Aurora, S. K., Dodick, D. W., Goadsby, P. J., Ge, Y., Bachman, R., Taraborelli, D., Fan, X., Assaid, C., Lines, C., & Ho, T. W. (2011). Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia, 31(6), 712-722. https://doi.org/10.1177/0333102411398399