Ubrogepant Use During Migraine Prodrome Improves Patient-Reported Outcomes

Ubprogepant significantly improves patient-reported outcomes when administered to patients during the prodrome phase of a migraine, according to study findings published in Neurology.

Study authors conducted a multicenter, randomized, double-blind, placebo-controlled, crossover trial (PRODROME; ClinicalTrials.gov Identifier: NCT04492020) between August 2020 and April 2022 at 73 sites in the United States to evaluate the effects of ubrogepant on patient-reported outcomes when administered during the migraine prodrome phase.

Adults aged 18 to 75 with at least a 1-year history of migraine and a history of 2 to 8 migraine attacks per month with moderate to severe headache pain were enrolled in the study. Participants who recorded 3 to 16 qualifying prodrome events, 75% of which were followed by a headache of any intensity within 1 to 6 hours, were randomly assigned 1:1 to treatment sequence A (placebo, followed by 100 mg ubrogepant) or B (ubrogepant 100 mg, followed by placebo). Patient-reported outcome measures included the ability to function normally over 24 hours, which was measured via the Functional Disability Scale (FDS); activity limitation over 24 hours; and satisfaction with study medication at 8 and 24 hours. Generalized estimating equation and linear mixed models were used in statistical analyses.

A total of 518 patients were randomly assigned to treatment, of whom 480 (mean age, 42.3; women, 87.7%; White, 88.1%; non-Hispanic, 92.7%) comprised the safety population, 477 comprised the modified intention to treat population, and 438 (84.6%) completed the trial. Failure to treat 2 qualifying prodrome events within the double-blind treatment period was the most common reason for discontinuation.

Among patients who treated a qualifying prodrome event, the response for the ability to function normally over 24 hours was significantly higher among patients treated with ubrogepant vs placebo (odds ratio [OR], 1.66; 95% CI, 1.40-1.96; P <.0001). As early as 2 hours following the dose, a greater proportion of qualifying events treated with ubrogepant vs placebo were associated with “no disability, able to function normally” (OR, 1.76; 95% CI, 1.32-2.35; P =.0001), an effect that was sustained through 24 hours (OR, 1.44; 95% CI, 1.01-2.06; P =.0457).

A greater proportion of qualifying prodrome events treated with ubrogepant vs placebo were associated with little or no activity limitations at 24 hours (OR, 2.07; 95% CI, 1.61-2.67; P <.0001). Further, a greater proportion of participants whose qualifying prodrome event was treated with ubrogepant vs placebo reported being “satisfied” or “extremely satisfied” with treatment at 8 (OR, 2.37; 95% CI, 1.78-3.15; P <.0001) and 24 (OR, 2.32; 95% CI, 1.78-3.02; P <.0001) hours after dose.

Adverse events were reported by 77 (16.9%) and 55 (11.9%) participants treated with ubrogepant and placebo, respectively. The most common AEs following either treatment were nausea, dizziness, fatigue, and somnolence.

Study limitations include potential recall bias and the homogeneity of the racial and ethnic makeup of the study population.

“Treatment with ubrogepant when administered during both the prodromal and headache phases can allow patients to achieve freedom from pain, absence of most bothersome symptoms, and a return to normal daily activities, supporting the use of this treatment for migraine relief,” the study authors concluded.

Disclosure: This research was supported by AbbVie. Some study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.