Common Migraine Prodromal Symptoms Improved Through Acute Ubrogepant

Author(s):

A greater proportion of patients on ubrogepant reported absence of moderate-to-severe intensity headache within 48 hours, ability to function normally, and absence of headache of any intensity.

David W. Dodick, MD

New data presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, showed that treatment with ubrogepant (Ubrelvy; AbbVie) 100 mg during the prodrome improved common migraine prodromal symptoms relative to placebo.

Led by David W. Dodick, MD, professor of neurology, Mayo Clinic Scottsdale, the PRODROME study (NCT04492020) was a multicenter, randomized, double-blind, placebo-controlled, crossover trial that included individuals with 2-8 migraine attacks with moderate-to-severe headache per month. The goal of the trial was to evaluate the efficacy ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine, to prevent or attenuate headache following administration during the prodrome.

The primary outcome measure was percentage of participants reporting absence of headache of moderate-to-severe intensity within 24 hours post-dose. Those included in the study treated 2 “qualifying prodrome events,” defined as a migraine attack with prodromal symptoms in which the participant was confident a headache would follow within 1-6 hours. Sometimes considered the premonitory phase, the migraine prodrome can consist of multiple possible symptoms of various types preceding and forewarning of a migraine attack, occurring before the aura in migraine with aura, and before the onset of pain in migraine without aura.

Prior to study drug administration, the most common prodromal symptoms reported in ubrogepant- and placebo-treated patients, respectively, were sensitivity to light (60.9% and 60.8%), fatigue (50.7% and 50.3%), neck pain (40.2% and 40.1%), sensitivity to sound (35.9% and 36.1%), and dizziness (29.0% vs 31.0%). Using an e-diary, between 30.8% and 57.2% of these symptoms at the time of each qualifying prodrome event were moderate or severe in intensity.

Within 24 hours of treatment, the absence of moderate-to-severe intensity headache was achieved following 45.5% of ubrogepant-treated qualifying prodrome events vs 28.6% of placebo-treated events (P <.0001). Furthermore, ubrogepant outperformed placebo on several other outcomes, including absence of moderate/severe intensity headache within 48 hours (40.7% vs 24.6%; P <.0001), ability to function normally over 24 hours (OR, 1.66; P <.0001), and absence of headache of any intensity within 24 hours (23.7% vs 13.9%; P <.0001). In addition, the safety profile of the ubrogepant remained consistent with previously observed.

Following treatment with ubrogepant 100 mg, the proportion of events with absence of sensitivity to light was numerically greater than those on placebo, starting 2 hours post-dose and extending through 48 hours (nominal P <.0109 for hours 2-8). Similar results were observed for the other common symptoms. Additionally, patients on study drug saw shorter time to absence of each individual prodromal symptom.

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REFERENCE
1. 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. Presented at: 2023 AAN Annual Meeting; April 22-27; Boston, MA. Abstract 001666