Document Type
Article
Publication Date
1-1-2023
Abstract
Background: Atogepant is a United States Food and Drug Administration-approved oral calcitonin gene-related peptide receptor antagonist for the preventive treatment of episodic migraine. The study objective was to evaluate the long-term safety and tolerability of atogepant in participants who completed the phase 3 ADVANCE trial (NCT03777059).
Methods: This 40-week, open-label extension trial (NCT03939312) monitored safety in participants receiving oral atogepant 60 mg once daily, followed by a four-week safety follow-up period.
Results: Of the 685 participants taking at least one dose of atogepant, the treatment period was completed by 74.6% of participants with a mean (standard deviation) treatment duration of 233.6 (89.3) days. Treatment-emergent adverse events occurred in 62.5% of participants, with upper respiratory tract infection (5.5%), urinary tract infection (5.3%), nasopharyngitis (4.8%), sinusitis (3.6%), constipation (3.4%), and nausea (3.4%) occurring at ≥3%. Serious adverse events were observed in 3.4% of participants (none were treatment-related), and there were no deaths. Adverse events leading to discontinuation occurring at >0.1% were nausea (0.4%) and abdominal pain, vomiting, weight decrease, dizziness, and migraine (0.3% each).
Conclusion: These results are consistent with atogepant's known safety profile and support long-term use of atogepant 60 mg once daily dosing as safe and well tolerated.ClinicalTrials.gov Registration Number: NCT03939312.
Recommended Citation
Klein, Brad C; Miceli, Rosa; Severt, Lawrence; McAllister, Peter; Mechtler, Laszlo; McVige, Jennifer; Diamond, Merle; Marmura, Michael J.; Guo, Hua; Finnegan, Michelle; and Trugman, Joel M, "Safety and Tolerability Results of Atogepant for the Preventive Treatment of Episodic Migraine From a 40-Week, Open-Label Multicenter Extension of the Phase 3 ADVANCE Trial" (2023). Department of Neurology Faculty Papers. Paper 311.
https://jdc.jefferson.edu/neurologyfp/311
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License
PubMed ID
36620892
Language
English
Comments
This article is the author’s final published version in Cephalalgia : an international journal of headache, Volume 43, Issue 1, January 2023, Pages 3331024221128250.
The published version is available at https://doi.org/10.1177/03331024221128250. Copyright © Klein et al.