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 < 0.001). Ubrogepant 100 mg was 
significantly superior to placebo for two-hour pain freedom (25.5% vs 8.9%) but 
not for two-hour headache response. Per the prespecified multiplicity strategy, 
this nonsignificant result precluded further formal hypothesis testing, although 
the 50 mg and 25 mg doses demonstrated nominal significance over placebo for 
two-hour pain freedom (unadjusted p < 0.05). Overall, adverse events were 
similar between ubrogepant and placebo.
CONCLUSION: This trial supports ubrogepant's efficacy and provides further 
evidence that CGRP-RAs are viable options for the acute treatment of migraine.