Background
What do we already know about this topic?
- Calcitonin gene–related peptide (CGRP) is a known trigger of migraine attacks.1,2
- Despite demonstrating efficacy in migraine treatment, the development of two early CGRP receptor antagonists was halted due to elevated alanine aminotransferase (ALT) in clinical trials.3,4
- Atogepant is a novel oral CGRP receptor antagonist in development for the prevention of migraine.
- In a 12-week Phase 2/3 randomized, placebo-controlled, clinical trial atogepant demonstrated efficacy and was well-tolerated at doses of 10 mg QD to 60 mg BID.1
How was this study conducted?
- A single-center, randomized, double-blind, placebo-controlled study of 34 participants aged 18 to 55 years randomized 2:1 to oral atogepant 170 mg or placebo once daily for 28 days.
- Outcome measures included change in plasma concentration and elimination half-life of atogepant, type and frequency of adverse events, and change from baseline in ALT.