Ubrogepant For The Treatment Of Migraine Prodromal Symptoms An Exploratory Analysis From The Randomized Phase 3 Prodrome Trial Peter J Goadsby Jessica Ailani David W Dodick Amaal J Starling Chengcheng Liu Yingyi Liu Sung Yun Yu Jonathan H Smith Elimor Brandschieber Joel M Trugman by Peter J. Goadsby & Jessica Ailani & David W. Dodick & Amaal J. Starling & Chengcheng Liu & Yingyi Liu & Sung Yun Yu & Jonathan H. Smith & Elimor Brand-schieber & Joel M. Trugman instant download after payment.

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 defned as attacks with symptoms in which the participant was confdent headache would follow within 1–6 h. Of 1,087 screened participants, 477 formed the efcacy 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% confdence interval (CI) = 1.13–2.61)); at 3 h post-dose, absence of fatigue occurred in 27.3% and 16.8% (OR = 1.85 (95% CI = 1.17–2.92)) and absence of neck pain in 28.9% and 15.9% (OR = 2.04 (95% CI = 1.25–3.32)) of events; at 4 h post-dose, absence of phonophobia in 50.7% and 35.8% (OR = 1.97 (95% CI = 1.38–2.80)) of events; and at 24 h post-dose, absence of dizziness in 88.5% and 82.3% (OR = 1.82 (95% CI = 1.00–3.30)) of events. At 1 h and 6 h post-dose, respectively, absence of difculty concentrating occurred in 8.7% and 2.1% (OR = 4.26 (95% CI = 1.17–15.54)) and absence of difculty thinking occurred in 56.9% and 41.8% (OR = 2.05 (95% CI = 1.14–3.71)) of events. Treatment with ubrogepant during the prodromal phase may ameliorate common prodromal symptoms, with improvements possibly as early as 1 h post-dose.