Document is current

Article History

Received: 16 December 2025

Accepted: 10 March 2026

First Online: 17 April 2026

Declarations

:

: Amaal J. Starling has received consulting fees from AbbVie, Allergan, Amgen, Amneal, Axsome Therapeutics, Eli Lilly, eNeura, Everyday Health, Impel, Lundbeck, Med-IQ, Medscape, Miller Medical, Neurolief, Novartis, Pfizer, Salvia, Satsuma, Teva, Theranica, UpToDate, WebMD, and Woodberry Associates. David Kudrow has served on advisory boards for AbbVie, Amgen, Axsome Therapeutics, Biohaven, Eli Lilly, and Lundbeck; and has served on speakers bureaus for AbbVie, Amgen, Axsome Therapeutics, Biohaven, Eli Lilly, and Teva. Neha Kapur, Susanne F. Awad, S. Wald Grossman, and Foram Patel are full-time employees of Lundbeck LLC or H. Lundbeck A/S. Jessica Ailani is an advisor for AbbVie, Aeon, Amgen, Axsome Therapeutics, Eli Lilly, GSK, Ipsen, Linpharma, Lundbeck, Merz, Pfizer, Satsuma, and Vectura; holds clinical trial grants from AbbVie, Ipsen, Lundbeck, and Parema; and is on the editorial board for SELF magazine. Andrew Blumenfeld has served on advisory boards for Allergan, Aeon, Alder, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, Pfizer, Revance, Teva, Theranica, and Tonix; has been a speaker for Allergan/AbbVie, Eli Lilly, Lundbeck, Teva, and Theranica; has consulted for Aeon, Allergan/AbbVie, Alder, Amgen, Biohaven, Eli Lilly, Lundbeck, Pfizer, Novartis, Teva, Theranica, and Tonix; has received grant support from Aeon, Allergan/AbbVie, Amgen, Lundbeck, and Revance; has been a contributing author for Aeon, Allergan/AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, Teva, and Theranica; and has received stock options from Haven Health Inc. and Aeon. Andrew Blumenfeld is an Editorial Board member of Pain and Therapy . Andrew Blumenfeld was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Richard B. Lipton serves on the editorial boards of Neurology and Cephalalgia and as senior advisor to Headache but is not paid for his roles with these journals; received research support from the National Institutes of Health and the National Headache Foundation; receives research grants from Allergan/AbbVie, Amgen, Dr. Reddy’s Laboratories, and Novartis; reviewed for the National Institute on Aging and National Institute of Neurological Disorders and Stroke; serves as a consultant or advisory board member for or received honoraria from Allergan/AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, GSK, Merck, Novartis, Teva, and Vedanta; receives royalties from Wolff’s Headache and Other Head Pain (eighth edition, Oxford University Press, 2009) and Informa; and holds stock options in Biohaven and Manistee.

: For the PREVAIL trial, an independent ethics committee and/or institutional review board provided trial approval at each site. This trial was conducted in accordance with Good Clinical Practice guidelines as referenced in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E6, local regulatory requirements, and the principles of the Declaration of Helsinki. All enrolled participants provided written informed consent prior to participating in the trial.