Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials.

"Declarations Ethics approval and consent to participateAll trials were performed in compliance with the International Conference on Harmonisation E6 Guideline for Good Clinical Practice and the principles of the Declaration of Helsinki. Each investigator obtained approval from an independent ethics committee or a local institutional review board. Before administration of any study procedures, participants provided written informed consent. Consent for publicationNot applicable. Competing interestsPR reports no relevant disclosures. MJM within the past 24 months, has received compensation for consultation from Alder/Lundbeck, Axsome, Satsuma, Supernus, and Theranica; has participated in speaker bureaus for Amgen/Novartis and Eli Lilly; has received institutional support for serving as principal investigator for Allergan/AbbVie, and Teva; and has received payments for authorship or royalties from Cambridge University Press, Demos Medical, and MedLink. JR has received grant support from Barrow Neurological Foundation and investigator support from AbbVie and Eli Lilly; has served as a speaker for Impel; has a paid editorial relationship with MedLink Neurological and Neurodiem; and discloses that a family member has partial ownership of Scottsdale Providence Recovery Center. JM has served as a speaker and/or received research support from Alder, Allergan (now AbbVie), Amgen/Novartis, Avanir, Biohaven, Eli Lilly, Lundbeck, and Teva. SS has participated in advisory boards and/or is a speaker for Allergan (now AbbVie), Amgen, BDSI, Biohaven, Eli Lilly, Impel NeuroPharma, and Teva. SJN has received honoraria for consulting from Alder/Lundbeck, Allergan/AbbVie, Axsome (ended January 2022), BioDelivery Sciences (ended February 2022), Biohaven (ended November 2021), Eli Lilly, Teva (ended October 2021), Theranica (ended September 2022); has received honoraria for speaking from Eli Lilly (ended September 2021); has received honoraria for work in education or publishing from American Academy of Neurology, American Headache Society, Evolve Med Ed, Massachusetts Medical Society, MedLink Neurology, MJH Life Sciences, NACCME, Neurology Learning Network, Pennsylvania Neurologic Society, Springer, WebMD/Medscape, Wolters-Kluwer; has received legal fees for serving as a medical expert to Jackson & Campbell. JA has served as a consultant for AbbVie, Aeon, Amgen, Biohaven, Eli Lilly, GlaxoSmithKline, Gore, Impel, Linpharma, Lundbeck, Miravo, Nesos, Neurolief, Pfizer, Satsuma, Teva, and Theranica; received stock options from Ctrl M; provided editorial services to Current Pain and Headache Reports, SELF, and Medscape; and received clinical trial support from AbbVie, Biohaven, Eli Lilly, Rehaler, Satsuma, and Zosano. RDF, JM, JHS, and BD are employees of AbbVie and may hold AbbVie stock. MA has received personal fees from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Lundbeck, Novartis, Pfizer and Teva; has participated in clinical trials as the principal investigator for AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis, Pfizer and Teva; has received research grants from Lundbeck Foundation, Novo Nordisk Foundation, and Novartis; serves as associate editor of Cephalalgia, associate editor of The Journal of Headache and Pain, and associate editor of Brain; and has no ownership interest and does not own stocks of any pharmaceutical company. Competing interests PR reports no relevant disclosures. MJM within the past 24 months, has received compensation for consultation from Alder/Lundbeck, Axsome, Satsuma, Supernus, and Theranica; has participated in speaker bureaus for Amgen/Novartis and Eli Lilly; has received institutional support for serving as principal investigator for Allergan/AbbVie, and Teva; and has received payments for authorship or royalties from Cambridge University Press, Demos Medical, and MedLink. JR has received grant support from Barrow Neurological Foundation and investigator support from AbbVie and Eli Lilly; has served as a speaker for Impel; has a paid editorial relationship with MedLink Neurological and Neurodiem; and discloses that a family member has partial ownership of Scottsdale Providence Recovery Center. JM has served as a speaker and/or received research support from Alder, Allergan (now AbbVie), Amgen/Novartis, Avanir, Biohaven, Eli Lilly, Lundbeck, and Teva. SS has participated in advisory boards and/or is a speaker for Allergan (now AbbVie), Amgen, BDSI, Biohaven, Eli Lilly, Impel NeuroPharma, and Teva. SJN has received honoraria for consulting from Alder/Lundbeck, Allergan/AbbVie, Axsome (ended January 2022), BioDelivery Sciences (ended February 2022), Biohaven (ended November 2021), Eli Lilly, Teva (ended October 2021), Theranica (ended September 2022); has received honoraria for speaking from Eli Lilly (ended September 2021); has received honoraria for work in education or publishing from American Academy of Neurology, American Headache Society, Evolve Med Ed, Massachusetts Medical Society, MedLink Neurology, MJH Life Sciences, NACCME, Neurology Learning Network, Pennsylvania Neurologic Society, Springer, WebMD/Medscape, Wolters-Kluwer; has received legal fees for serving as a medical expert to Jackson & Campbell. JA has served as a consultant for AbbVie, Aeon, Amgen, Biohaven, Eli Lilly, GlaxoSmithKline, Gore, Impel, Linpharma, Lundbeck, Miravo, Nesos, Neurolief, Pfizer, Satsuma, Teva, and Theranica; received stock options from Ctrl M; provided editorial services to Current Pain and Headache Reports, SELF, and Medscape; and received clinical trial support from AbbVie, Biohaven, Eli Lilly, Rehaler, Satsuma, and Zosano. RDF, JM, JHS, and BD are employees of AbbVie and may hold AbbVie stock. MA has received personal fees from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Lundbeck, Novartis, Pfizer and Teva; has participated in clinical trials as the principal investigator for AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis, Pfizer and Teva; has received research grants from Lundbeck Foundation, Novo Nordisk Foundation, and Novartis; serves as associate editor of Cephalalgia, associate editor of The Journal of Headache and Pain, and associate editor of Brain; and has no ownership interest and does not own stocks of any pharmaceutical company."

"Funding AbbVie funded this trial and contributed to the study design, the collection, analysis, and interpretation of data, and the review and approval of the final version for publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship."

"Trial registration ClinicalTrials.gov identifiers: NCT02848326 (MD-01), NCT03777059 (ADVANCE), NCT03700320 (study 302), NCT03939312 (study 309)."