Ubrogepant for the treatment of migraine prodromal symptoms: an exploratory analysis from the randomized phase 3 PRODROME trial.

ABSTRACT: PRODROME was a phase 3, placebo-controlled, double-blind crossover trial evaluating whether ubrogepant 100 mg, a calcitonin gene-related peptide receptor antagonist, dosed during the premonitory (prodromal) phase of migraine, prevented development of headache and resolved prodromal symptoms. Qualifying prodromal events were defined as attacks with symptoms in which the participant was confident headache would follow within 1-6 h. Of 1,087 screened participants, 477 formed the efficacy analysis population. Outcomes were collected across 48 h showing, for example, at 2 h post-dose, absence of photophobia in 19.5% and 12.5% of ubrogepant- and placebo-treated events, respectively (odds ratio (OR) = 1.72 (95% confidence interval (CI) = 1.13-2.61)); at 3 h post-dose, absence of fatigue occurred

SUBMITTER: Goadsby PJ 

PROVIDER: S-EPMC12283353 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature