Patients across all dosing groups saw statistically significant and clinically relevant reductions in migraine days during the 12-week treatment period compared with the placebo group.
Peter J. Goadsby, MD, PhD
Patients with migraine who received doses of atogepant 10 mg to 60 mg experienced a statistically significant and clinically relevant reduction in mean migraine days compared with placebo, according to results of a phase 2b/3 study presented at the 2019 American Academy of Neurology Annual Meeting
, May 4-10 in Philadelphia.
The trial, led by Peter J. Goadsby, MD, PhD, professor of neurology at King’s College London and University of California, San Francisco, evaluated the safety, efficacy, and tolerability of the novel, oral CGRP receptor antagonist for the prevention of episodic migraine.
“These exciting results demonstrate the potential for atogepant for a broad spectrum of migraine patients,” Goadsby said in a statement. “The efficacy and safety across doses and dose regimens show promise in a patient population with high unmet treatment needs.”
The multicenter, randomized, double-blind, placebo-controlled study (NCT02848326) included 834 adults with a history of migraine with or without aura, who reported between 4 to 14 migraine days during a 28-day baseline period. Mean age of participants was 40.1 years, with the majority of patients being white (76.1%) females (86.5%), most of whom were naïve to preventive treatments for migraine (71.9%).
Patients were randomly assigned to receive either placebo or atogepant 10 mg once daily, 30 mg once-daily, 30 mg twice daily, 60 mg once daily, or 60 mg twice daily for 12 weeks.
Over the 12-week treatment period, patients who received atogepant experienced the following mean change in migraine days: 10 mg once daily (-4.00, P
=.0236), 30 mg once daily (-3.76, P
=.0390), 30 mg twice daily (‑4.23, P
=.0034), 60 mg once daily (-3.55, P
=.0390), 60 mg twice daily (-4.14, P
=.0031). Comparably, patients who received placebo experienced a mean change of -2.85 in migraine days.
Overall, 58.2% of participants reported treatment-emergent adverse events, 20.6% of whom felt the adverse events were treatment-related. Serious adverse events were reported in 7 patients, none of which were considered treatment-related. Notably, there were 10 cases of treatment-emergent ALT/AST elevations more than 3 times normal levels across all treatment groups.
“Results from this atogepant trial provide continued evidence for the clinical potential of oral CGRP antagonists and the substantial value of progressing research and developing new treatments for migraine patients,” Goadsby said.
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1. Goadsby PJ, Dodick DW, Trugman JM, et al. Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia. PA.
2. Allergan's oral CGRP receptor antagonist atogepant demonstrates robust efficacy and safety in episodic migraine prevention in a phase 2b/3 clinical trial [news release]. Dublin, Ireland: Allergan. June 11, 2018. Accessed May 8, 2019. https://www.prnewswire.com/news-releases/allergans-oral-cgrp-receptor-antagonist-atogepant-demonstrates-robust-efficacy-and-safety-in-episodic-migraine-prevention-in-a-phase-2b3-clinical-trial-300663770.html