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A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine

Aim The aim of this trial was to evaluate the efficacy and tolerability of ubrogepant (MK-1602), a calcitonin gene-related peptide receptor antagonist (CGRP-RA), for the acute treatment of migraine. Methods This double-blind, placebo-controlled study randomized 834 participants to treat one migraine...

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Bibliographic Details
Published in:Cephalalgia 2016-08, Vol.36 (9), p.887-898
Main Authors: Voss, Tiffini, Lipton, Richard B, Dodick, David W, Dupre, Nicole, Ge, Joy Yang, Bachman, Robert, Assaid, Christopher, Aurora, Sheena K, Michelson, David
Format: Article
Language:English
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Summary:Aim The aim of this trial was to evaluate the efficacy and tolerability of ubrogepant (MK-1602), a calcitonin gene-related peptide receptor antagonist (CGRP-RA), for the acute treatment of migraine. Methods This double-blind, placebo-controlled study randomized 834 participants to treat one migraine attack with ubrogepant 1 mg, 10 mg, 25 mg, 50 mg, 100 mg, or placebo in a 1:1 ratio. The co-primary endpoints were pain freedom and headache response at two hours. The first primary hypothesis tested the dose-response trend for two-hour pain freedom using a logistic regression model. Subsequent hypotheses tested the effects of each dose on the co-primary endpoints, using a closed sequential testing procedure to control for multiplicity. Results A total of 527 participants received ubrogepant and 113 received placebo. A positive response trend in the proportion of participants achieving two-hour pain freedom was demonstrated (p 
ISSN:0333-1024
1468-2982
DOI:10.1177/0333102416653233