New treatment for migraine
Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist under investigation for treatment of migraine.
In a double-blind, phase 2b/3 trial, adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month, the investigators randomly assigned 2:1:2:2:1:1 (by means of a sequence generated by the statistical programming department of the sponsor, and operationalised through an automated interactive web-based response system) to receive placebo or atogepant 10 mg once daily, 30 mg once daily, 60 mg once daily, 30 mg twice daily, or 60 mg twice daily, in matching capsules.
The study was done in 78 academic and private practice settings in the USA. The primary outcome was change from baseline in monthly migraine days across 12 weeks of treatment using a modified intention-to-treat approach. The overall type I error rate for multiple comparisons across active treatment doses was controlled at the 0·05 level by means of a graphic approach. The main outcomes to assess safety and tolerability were adverse event recordings.
The trial is registered with ClinicalTrials.gov, NCT02848326 and is completed.
All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.
Atogepant was safe and well tolerated over 12 weeks, supporting its phase 3 development for the preventive treatment of migraine.