Ubrogepant for Acute Migraine
(2019)Objective
Ubrogepant - To evaluate the efficacy and safety of ubrogepant, an oral CGRP receptor antagonist, for acute treatment of migraine with or without aura.
Study Summary
• Common adverse events included nausea, somnolence, and dry mouth, mostly mild.
• No serious safety concerns identified with single-dose use.
Intervention
Randomized, double-blind, placebo-controlled trial of 1672 adults with migraine (with or without aura), conducted at 89 US centers. Participants received placebo, ubrogepant 50mg, or ubrogepant 100mg for a single migraine attack. Efficacy and adverse events were assessed over 48 hours.
Inclusion Criteria
Adults aged 18–75 with ≥1 year of migraine history, 2–8 migraine attacks/month, and moderate/severe pain at onset. Excluded if chronic migraine, cardiovascular disease, hepatic dysfunction, or recent CGRP antibody use.
Study Design
Arms: Placebo vs. Ubrogepant 50mg vs. Ubrogepant 100mg
Patients per Arm: Placebo: 456, Ubrogepant 50mg: 423, Ubrogepant 100mg: 448
Outcome
• Absence of most bothersome symptom at 2h: 27.8% (placebo), 38.6% (50mg), 37.7% (100mg); p=0.002
• Sustained pain relief (2–24h): 20.8% (placebo), 36.3% (50mg), 38.0% (100mg); p=0.002
• Common adverse events: nausea (up to 4.1%), somnolence (2.5%), dry mouth (2.1%)
• Serious AEs within 30d: appendicitis, seizure, spontaneous abortion; none occurred within 48h post-dose.