Improvement in Patient-Reported Outcomes When Ubrogepant Is Administered During the Migraine Prodrome (Premonitory Phase): Results From the PRODROME Trial

Improvement in Patient-Reported Outcomes When Ubrogepant Is Administered During the Migraine Prodrome (Premonitory Phase): Results From the PRODROME Trial

Background: Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine.

Purpose/Objectives: To characterize the improvement in patient-reported outcomes when ubrogepant is administered during the migraine prodrome (premonitory phase).. The PRODROME (NCT04492020) trial demonstrated that treatment during the prodrome prevents the onset of moderate or severe headache and reduces functional disability. Here we examine the benefits of treatment during the prodrome on patient-reported outcomes.

Method:

This was a multicenter, randomized, double-blind, placebo-controlled, crossover trial that enrolled adults who experienced 2-8 migraine attacks per month with moderate to severe headache. Eligible participants 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. Participants were randomized to treatment Sequence A (placebo then ubrogepant 100 mg) or Sequence B (ubrogepant 100 mg then placebo). This analysis evaluated the ability to function normally over 48 hours, activity limitation over 24 hours, and satisfaction with study medication at 8 and 24 hours.

Results:

Following treatment of qualifying prodrome events, higher rates of ability to function normally over 24 hours were observed following treatment with ubrogepant 100 mg compared with placebo (P< 0.0001). Ubrogepant treatment was associated with a higher rate of ability to function normally as early as 2 hours post-dose compared with placebo (37.0% vs 26.1%; nominal P=0.0001). Ubrogepant-treated events also demonstrated higher rates of little or no activity limitations over 24 hours post-dose (65.4% vs 47.8%; nominal P< 0.0001). At 24 hours post-dose, rates of being “satisfied” or “extremely satisfied” were higher for ubrogepant than placebo (65.6% vs 45.0%; nominal P< 0.0001).

Conclusions: Ubrogepant 100 mg administered during the prodrome was associated with significantly greater ability to function normally, greater satisfaction with study medication, and reductions in activity limitation compared with placebo.

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results from a phase 3, randomized, double-blind, placebo-controlled, crossover study. Abstract presented at AAN 2023.