In:
Cephalalgia, SAGE Publications, Vol. 31, No. 6 ( 2011-04), p. 712-722
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.
Type of Medium:
Online Resource
ISSN:
0333-1024
,
1468-2982
DOI:
10.1177/0333102411398399
Language:
English
Publisher:
SAGE Publications
Publication Date:
2011
detail.hit.zdb_id:
2019999-5
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