The following is a summary of “Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial,” published in the August 2024 issue of Neurology by Lipton et al.
Researchers conducted a retrospective analysis of the PRODROME trial to assess the impact of ubrogepant treatment during the prodrome on patient-reported outcomes.
They conducted PRODROME, a multicenter, randomized, double-anonymized, placebo-controlled, crossover trial that enrolled adults with 2-8 monthly migraine attacks with moderate-severe headache pain. Eligible participants treated 2 qualifying prodrome events, identified as a migraine attack with prodromal symptoms when they were confident a headache would start within 1-6 hours. Participants were randomized to treatment sequence A (placebo followed by ubrogepant 100 mg) or sequence B (ubrogepant 100 mg followed by placebo). The analysis assessed normal functioning over 24 hours and at specific post-dose times. Other PRO endpoints were activity limitation over 24 hours and medication satisfaction at 8 and 24 hours.
The results showed 518 randomized participants, 477 of whom were in the modified intent-to-treat group. Ubrogepant 100 mg significantly improved normal functioning over 24 hours compared to placebo (OR 1.66, 95% CI 1.40–1.96; P<0.0001). Two hours after dosing, more ubrogepant users reported “no disability” compared to placebo (OR 1.76, 95% CI 1.32–2.35; nominal P=0.0001). Ubrogepant also reduced activity limitations for more than 24 hours (OR 2.07, 95% CI 1.61–2.67; nominal P<0.0001). Satisfaction rates at 8 and 24 hours were higher with ubrogepant (8 hours: OR 2.37, 95% CI 1.78–3.15; nominal P<0.0001; 24 hours: OR 2.32, 95% CI 1.78–3.02; nominal P<0.0001).
They found that ubrogepant 100 mg, taken during the migraine prodrome, significantly improved functionality, reduced activity limitations, and increased patient satisfaction compared to placebo.
Source: neurology.org/doi/10.1212/WNL.0000000000209745
