Ubrogepant treatment used during the prodrome phase of a migraine prevented headache within 24 hours and reduced functional disability more than placebo, according to study results presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, held from April 22 to 27, in Boston, Massachusetts.
The calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant is approved for the treatment of acute migraine. Preceding the onset of migraine, the prodrome is an early phase of migraine attack that is characterized by nonaura symptoms.
For this phase 3, randomized, double-blind, placebo-controlled, crossover study, PRODROME (ClinicalTrials.gov Identifier: NCT04492020), researchers determined whether the use of 100 mg ubrogepant in the prodrome phase may prevent or attenuate the onset of headache and associated disability. Patients (N=480) with migraine were instructed to treat 2 qualifying prodrome events with ubrogepant or placebo, in a randomized order, when they were confident a headache would follow in 1-6 hours. The primary outcome was prevention of moderate or severe headache within 24 hours of treatment.
More ubrogepant-treated events prevented a moderate or severe intensity headache within 24 hours (45.5%) compared with placebo-treated events (P <.0001). Similar trends at 48 hours were observed (40.7% vs 24.6%; P <.0001) for ubrogepant- and placebo-treated prodrome, respectively.
More ubrogepant-treated events associated with an absence of any headache at 24 hours compared with placebo (23.7% vs 13.9%; P <.0001), respectively.
Ubrogepant was also associated with an increased likelihood of normal functioning at 24 hours (odds ratio [OR], 1.66; P <.0001) compared with placebo.
The safety signals of ubrogepant were consistent with the known profile.
The major limitation of this study was that some patients may not be as adept at predicting headache onset on the basis of prodrome symptoms.
This study found evidence that the use of ubrogepant during the prodrome phase of a migraine prevented many moderate to severe headaches in the 48 hours post-dose. These data led the researchers to conclude, “Treatment with ubrogepant 100 mg during the prodrome prevented the development of moderate/severe headache for 24 and 48 hours postdose and headache of any intensity within 24 hours and reduced functional disability compared with treatment with placebo.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Neurology Advisor
Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the acute treatment of migraine when administered during the prodrome (premonitory phase): results from a phase 3, randomized, double-blind, placebo-controlled, crossover study. Abstract presented at: 2023 AAN Annual Meeting; April 22-27, 2023; Boston, MA. Abstract S47.001.