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Practice Guideline
. 2025 Apr;45(4):3331024251321500.
doi: 10.1177/03331024251321500. Epub 2025 Apr 25.

Evidence-based guidelines for the pharmacological treatment of migraine, summary version

Raffaele Ornello  1 Valeria Caponnetto  2 Fayyaz Ahmed  3 Haidar M Al-Khazali  4 Anna Ambrosini  5 Sait Ashina  6   7 Carlo Baraldi  8 Alessia Bellotti  9 Filippo Brighina  10 Paolo Calabresi  11   12 Francesco Casillo  13 Sabina Cevoli  14 Shuli Cheng  15 Chia-Chun Chiang  16 Alberto Chiarugi  17 Rune Häckert Christensen  4   7   18   19 Min Kyung Chu  20 Gianluca Coppola  13 Ilenia Corbelli  9 Santiago Crema  21 Roberto De Icco  22   23 Marina De Tommaso  24 Cherubino Di Lorenzo  13 Vincenzo Di Stefano  10 Hans-Christoph Diener  25 Esme Ekizoglu  26 Adriana Fallacara  24 Valentina Favoni  14 Kimberly N Garces  27 Pierangelo Geppetti  28 Maria Teresa Goicochea  21 Antonio Granato  29 Franco Granella  30 Simona Guerzoni  8 Woo-Seok Ha  31 Amr Hassan  32 Koichi Hirata  33 Jan Hoffmann  34 Eva-Maria Hüssler  35 Mona Hussein  36 Luigi Francesco Iannone  16 Bronwyn Jenkins  37 Alejandro Labastida-Ramirez  34 Anna Laporta  24 Morris Levin  38 Antonino Lupica  10 Edoardo Mampreso  39 Daniele Martinelli  22 Teshamae S Monteith  27 Ilaria Orologio  40 Aynur Özge  41 Li-Ling Hope Pan  42 Lavindren Luke Panneerchelvam  3 Mario Fp Peres  43 Marcio Nattan Portes Souza  44 Patricia Pozo-Rosich  45   46 Maria Pia Prudenzano  47 Silvia Quattrocchi  14 Innocenzo Rainero  48 Volodymyr Romanenko  49 Marina Romozzi  11   12 Antonio Russo  40 Grazia Sances  22 Paola Sarchielli  9 Todd J Schwedt  50 Marcello Silvestro  40 Diego Belardino Swerts  43 Cristina Tassorelli  22   23 Alessandro Tessitore  40 Mansoureh Togha  51   52 Gloria Vaghi  22   23 Shuu-Jiun Wang  53   54 Messoud Ashina  4   18 Simona Sacco  1
Affiliations
Free article
Practice Guideline

Evidence-based guidelines for the pharmacological treatment of migraine, summary version

Raffaele Ornello et al. Cephalalgia. 2025 Apr.
Free article

Abstract

We here present evidence-based guidelines for the pharmacological treatment of migraine. These guidelines, created by the Italian Society for the Study of Headache and the International Headache Society, aim to offer clear, actionable recommendations to healthcare professionals. They incorporate evidence-based recommendations from randomized controlled trials and expert-based opinions. The guidelines follow the GRADE approach for assessing the quality of evidence. The guideline development involved a systematic review of literature across multiple databases, adherence to Cochrane review methods, and a structured framework for data extraction and interpretation. Although the guidelines provide a robust foundation for migraine treatment, they also highlight gaps in current research, such as the paucity of head-to-head drug comparisons and the need for long-term outcome studies. These guidelines serve as a resource to standardize migraine treatment and promote high-quality care across different healthcare settings.

Keywords: acute treatment; drugs; migraine treatment; pharmacological treatments; preventive treatment.

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Conflict of interest statement

Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:R.O.: Consulting fees, Allergan-AbbVie, Eli Lilly. Honoraria: Eli Lilly, Novartis, Pfizer, Teva. Support for attending meetings, Allergan-AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, Teva. Participating, Allergan-AbbVie, Eli Lilly. Leadership, Jr. Editorial Board member J Headache Pain. Receipt of equipment, Novartis, Eli Lilly. Other financial or non-financial, Eli Lilly, Novartis, TevaV.C.: Honoraria, Teva. Support for attending meetings, TevaF.A.: Received honorarium to be on the ad board and lecturing from AbbVie, Pfizer, Eli Lilly, TEVA, Lundbeck. Leadership, Treasurer, IHS.H.M.A.-K.: Support for present manuscript, H.M.A.-K. reports personal fees from Pfizer, outside of the submitted work.A.A.: Honoraria, Speakers by Novartis, Teva, Eli-Lilly, Pfizer. Congress attendance supported by Teva. Leadership, Secretary for Italian Headache Society.S.A.: Consulting: Allergan/AbbVie, Eli Lilly, Impel NeuroPharma, Linpharma, Lundbeck, Pfizer, Satsuma, Teva, Theranica. Honoraria, Lectures presentations: AbbVie, Eli Lilly, Teva, Pfizer, Lundbeck. Leadership: Associate Editor for Cephalalgia, BMC Neurology, Frontiers in Neurology, Headache and Pain Research, Neurology Reviews, and Trustee of the International Headache Society Board.C.B.: Honoraria, AbbVie. Support for meeting attendance, AbbVie, Lilly, Pfizer, LundbeckF.B.: Received honoraria for lectures, presentations from: Pfizer, Lilly, TEVA, Alnylam, AbbVie, Lundbeck, Alexion. Support for attending meetings, TEVA, Alnylam, Roche, Sanofi, Biogen, AbbVie, Alexion, Lundbeck, Lilly.P.C.: Received speaker honoraria from: AbbVie, Bayer Schering, Bial, Biogen-Dompè, Biogen-Idec, Eisai, Genzyme, Lundbeck, Lusofarmaco, Merck- Serono, Novartis, Prexton, Teva, UCB Pharma, Zambon. PC received support to attend national and international conferences from: AbbVie, Bayer Schering, Bial, Biogen-Dompè, Biogen-Idec, Eisai, Genzyme, Lundbeck, Lusofarmaco, Merck-Serono, Novartis, Prexton, Teva, UCB Pharma, Zambon. Participation on Advisory Board for Lilly. Participation in Data Safety, Roche, Therapy for Parkinson's Disease. PC is Past President of the Società Italiana per lo Studio delle Cefalee (SISC)S.C.: Honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for Angelini, Teva, Novartis, AbbVie, Lundbeck, Pfizer. Support for attending meetings and/or travel by AbbVie, Lilly. Participation on Advisory Board for Lilly. Advisor of ANIRCEF. PI for trial of Lilly, Novartis, Teva, Lundbeck.S.C.: Headache Australia website medical reviewer. AbbVie to attend 2022 Australia New Zealand Neurologist Association ASM. ordinary committee member on the Australian New Zealand Headache Society- current.C.C.C.: Research support from the American Heart Association with funds paid to her institution. (Unrelated to this manuscript). Consulting, Satsuma, eNeura. Honoraria, HMP Global for migraine education lectures. Leadership, American Migraine Foundation Editorial Board.A.C.: Filed patents on novel uses of anti-CGRP biologics and gepants.R.H.C.: IHEAD support from IHS. Travel support from the Augustinus Foundation.M.K.C.: Honoraria, Allergan Korea, Handok-Teva, Eli Lilly and Company, and Yuyu Pharmaceutical Company.G.C.: Consulting fees, Pfizer, AbbVie. Honoraria, Pfizer, Lilly. Meeting support, TEVA, Lilly, Pfizer. Safety boards, Pfizer, AbbVie. Leadership, Trustee and co-chair of the membership committee for the International Headache Society, member of the board at large of the European Headache Federation, Secretary and member of the study center of the Italian Society for the Study of Headaches, member of the Special Interest Group on Brainstem of the International Federation of Clinical Neurophysiology.S.C.: Funding for travel, accommodation and congress registration provided by Pfizer.R.D.I.: Honoraria from Eli-Lilly; TEVA; Lundbeck. Funding support for meeting attendance, TEVA; Lundbeck. Advisory boards, Pfizer; AbbVie.M.D.T: Honoraria, presentations in national conferences supported by TEVA, Lundbeck, Pfizer, Lilly. Support from TEVA for EHF last meeting in Barcelona. Leadership, President Elected Italian Society for Headache study (SISC).C.D.L.: Consulting, Pfizer. Honoraria, Pfizer, Eli Lilly.V.D.S.: Support for travels for attending meetings from Alexion, Alnylam, Argenx. V.D.S. is member of Italian Society of Neurology (SIN), Italian Society for the Study of Headache (SISC), Italian Society of Peripheral Nervous System (ASNP), Italian Society of Clinical Neurophysiology (SINC). V.D.S. received compensation for speaking from Alexion, and Alnylam; he is Sub-Investigator in clinical trials for Alexion, Alnylam, Argenx, Dianthus, and Sanofi.H.-C.D.: Grants from German Research Council. Honoraria, Lundbeck, Novartis, Teva. Leadership, Clinical trials committee of the IHS NorHead Norway.E.E.: Received honoraria for the preparation of educational materials from Allergan-AbbVie.V.F.: Grants from AbbVie, Eli-Lilly, Lundbeck, Pfizer and Teva. Consulting fees from AbbVie, Eli-Lilly and Teva. Honoraria from Eli-Lilly, Lundbeck, Pfizer and Teva. Support for attending meetings, AbbVie and Teva. Advisory board, AbbVie.P.G.: European Research Council - Advanced grant € 2,185,921; European research Council - Proof of Concept grant € 150,000; Royalties for books of the series Handbook of Experimental Pharmacology, Springer. Compensations varied between € 300 to 2100 per year; Pfizer; Eli Lilly; AbbVie; Lundbeck; Allergan; TEVA; Novartis: compensations varied between € 800 and € 4500. Recipient of 3 Patents (102021000015095, 102021000015098, 102021000029894) own by FloNext Srl. Current value € 0. President, Italian Society for the Study of Headache. Compensation € 0. Founder and shareholder of the Academic Spinoff (University of Florence) FloNext Srl; Current value € 0.M.T.G.: Independent Medical Education Grant from Pfizer. Speaker or advisory board from, Teva, AbbVie, Pfizer. Support for attending meetings AbbVie, Pfizer.A.G.: Lectures supported by Lilly, TEVA, Novartis, AbbVie. Educational meeting supported by Lilly, TEVA, AbbVie.F.G.: Honoraria from Lundbeck and Pfizer. Leadership, President of the Italian Society for the Study of Headaches (SISC).S.G.: Consulting fees, AbbVie, Lilly, Angelini, Pfizer, Lundbeck. Honoraria, AbbVie, Lilly, Angelini, Pfizer, Lundbeck. Meeting attendance, AbbVie, Lilly, Pfizer, Lundbeck. Advisory boards, AbbVie, Lilly, Angelini, Pfizer, Lundbeck,W.-S.H.: Lecture on online education program for nursing patients with epilepsy in request of Korean Nurse association (2024-01-17).A.H.: Consulting fees, Novartis, Sanofi Genzyme, Biologix, Merck, Hikma Pharma, Janssen, Inspire Pharma, Future Pharma, Elixir pharma. Honoraria for lectures/ presentations: Novartis, Allergan, Merck, Biologix, Janssen, Roche, Sanofi Genzyme, Bayer, Hikma Pharma, Al Andalus, Chemipharm, Lundbeck, Inspire Pharma, Future Pharma and Habib Scientific Office, and Everpharma. Support for attending meetings, congresses, symposia and/or travel: Novartis, Allergan, Merck, Biologix, Roche, Sanofi Genzyme, Bayer, Hikma Pharma, Chemipharm, and Al Andalus and Clavita pharm. Advisory boards, Clavita pharm Advisory board: Novartis, Sanofi Genzyme, Biologix, Merck, Hikma Pharma, Janssen, Inspire Pharma, Future Pharma, Elixir pharma. Leadership, Member of Education committee of IHS Member of Membership committee of IHS Member of regional societies committee of IHS Vice President of MENAA headache society Secretary General of headache chapter of Egyptian society of Neurology.K.H.: Consulting, Otsuka Pharmaceutical Co., Ltd. Honoraria, Amgen Astellas BioPharma K.K., Daiichi Sankyo Company, Limited, Eisai Co., Ltd., Eli Lilly Japan K.K., MSD Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc. Support for meeting attendance, Amgen Astellas BioPharma K.K., Daiichi Sankyo Company, Limited, Eisai Co., Ltd., Eli Lilly Japan K.K., MSD Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc. Advisory boards, Amgen Astellas BioPharma K.K., Eli Lilly Japan K.K., MSD Co., Ltd., Otsuka Pharmaceutical Co., Ltd Leadership, Japan Patient Advocacy CoalitionJ.H.: In the past 36 months I held or still hold research grants from the following entities (unrelated to this manuscript): Bristol Myers Squibb Migraine Trust International Headache Society National Institute for Health and Care Research (NIHR) Medical Research Council (MRC). Consulting and/or advisory boards for AbbVie, Cannovex, Chordate Medical, Eli Lilly, Lundbeck, Sanofi, Teva. Lectures/speaking/educational events: Chordate Medical, MD-Horizonte, Lundbeck, Teva. Manuscript writing/associate editor work: NEJM Journal Watch, Oxford University Press, Quintessence Publishing, Sage Publishing, Springer Healthcare. Data Monitoring Committee: Chordate Medical. Advisory Board: AbbVie, Chordate Medical, Eli Lilly, Lundbeck, Teva.Board of Trustees of the International Headache Society. Council Member and Treasurer of the British Association for the Study of Headache. Associate Editor for Cephalalgia, Cephalalgia Reports, J Headache Pain, Frontiers in Pain Research, Journal of Oral & Facial Pain and Headache. Stock options for Chordate Medical.L.F.I.: IHS junior grant. Consulting fees, Eli-Lilly, AbbVie. Honoraria, Eli-Lilly, AbbVie, Pfizer, TEVA. Meeting attendance support, TEVA, Lundbeck.B.J.: Honoraria, Allergan/AbbVie, Eli Lilly, GPCE, HealthEd, Lundbeck, Pfizer, Teva. Leadership, President of the Australian and New Zealand Headache Society.A.L.H.: Grants, ALR was supported by a fellowship from the Migraine Trust.M.L.: Royalties, Oxford University Press $600. Advisory boards $6000. Expert testimony, $5000. Bd of Directors Headache Cooperative of the Pacific Unpaid.E.M.: Honoraria, AbbVie, Elli-Lilly, TEVA, Pfizer, Lundbeck. Meeting attendance support, AbbVie, Elli-Lilly, TEVA, Pfizer, LundbeckD.M.: LSC LifeSciences Consultants. Honoraria, AbbVie, Lundbeck.T.S.M.: Grants from AbbVie, Amgen Site PI: Rehaler, AbbVie, Eli Lilly. Consulting fees, Pfizer, AbbVie, Merz. Honoraria, Medscape, American Headache Society, American Academy of Neurology. Novartis, Massachusetts Medical Society. Advisory boards, Teva, Pfizer, AbbVie, eNeura, LinPharma. Leadership: IHS Board of Trustee, Florida Society of Neurology, American Headache Society, American Academy of Neurology, American Neurological Association, Editorial Boards: Cephalalgia, Neurology, Brain and Life Magazine, American Migraine Foundation, Continuum Audio.A.Ö.: Consulting fees, AbbVie, Drogsan, ABdi İbrahim. Honoraria, AbbVie, Drogsan, ABdi İbrahim. President of Global Migraine and Pain Society, President of Mersin Alzheimer Society, Board member of IHS.M.F.P.P.: Consulting fees, AbbVie, Pfizer, Lundbeck, Eurofarma, Libbs, Teva, Lilly. Honoraria, AbbVie, Pfizer, Lundbeck, Eurofarma, Libbs, Teva, Lilly. Patents, BR 10 2020 020706-7 US 11,826,177 B2. Advisory boards, AbbVie, Pfizer, Lundbeck, Eurofarma, Teva. Leadership, IHS, ABRACES.M.N.P.S.: Honoraria, Libbs, TEVA, Pfizer, Allergan/AbbVie, Lundbeck. Funding for traveling to the IHC 2023, by TEVA. Advisory boards, Pfizer, TEVA, Libbs.P.P.-R.: Her research group has received research grants from AbbVie, Novartis and Teva; as well as, Instituto Salud Carlos III, EraNet Neuron, European Regional Development Fund (001-P-001682) under the framework of the FEDER Operative Programme for Catalunya 2014-2020 - RIS3CAT; has received funding for clinical trials from AbbVie, Amgen, Biohaven, Eli Lilly, Novartis, Teva. Received, in the last 36 months, honoraria as a consultant for: AbbVie, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer and Teva. Received, in the last three years, honoraria as a speaker for: AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer and Teva. Norwegian Clinical Trial driven by the investigator. She is the Honorary Secretary of the International Headache Society. She is on the editorial board of Revista de Neurologia. She is an associate editor for Cephalalgia, Headache, Neurologia, The Journal of Headache and Pain and Frontiers of Neurology. She is a member of the Clinical Trials Guidelines Committee of the International Headache Society. She has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society.M.P.P.: Consulting fees, Pfizer, Teva. Honoraria, AbbVie, Allergan, Eli-Lilly, Idorsia, Italfarmaco, Lundbeck, Pfizer, Teva, Valeas. Meeting attendance support, Idorsia, Lilly, Lundbeck, Teva. Advisory boards, Allergan, Lilly, Lundbeck, Pfizer, Teva. Leadership, Italian Society for the Study of Headache (SISC), Italian Society of Neurology,I.R.: Honoraria, Pfizer, Eli Lilly Italy, Teva. Support for meeting attendance, AbbVie. Advisory board, Pfizer,V.R.: Ukrainian Headache Research Society, PresidentA.R.: Honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (in past 36 months) from Ely-Lilly, AbbVie, Teva Pharmaceuticals, Pfizer. Support for attending meetings and/or travel (past 36 months) from Ely-Lilly, AbbVie, Teva Pharmaceuticals, Pfizer. Participation on a Data Safety Monitoring Board or Advisory Board (past 36 months) from Ely-Lilly, AbbVie, Teva Pharmaceuticals, Pfizer. Member of executive board of the Italian Headache Society (S.I.S.C.)G.S.: Royalties, Novartis, Eli Lilly, Teva, Lundbeck, Pfizer. Consulting, Novartis, Eli Lilly, Teva, Lundbeck, Pfizer. Honoraria, Novartis, Eli Lilly, Lundbeck, Pfizer. Expert testimony, Novartis, Eli Lilly, Teva, Lundbeck, Pfizer. Stock options, Eli Lilly, Pfizer.P.S.: Presentation and moderations for Eli-Lilly and Lundbeck. Annual congress of SISC and for Florence Symposium on CGRP (2022, 2023). Leadership, Didactic Leader for High School of Headache of SISC Italian society.T.J.S.: American Heart Association, American Migraine Foundation, Amgen, Henry Jackson Foundation, Mayo Clinic, National Headache Foundation, National Institutes of Health, Patient Centered Outcomes Research Institute, Pfizer, Spark Neuro, United States Department of Defense. Royalties licenses, AbbVie, Allergan, Amgen, Axsome, Biodelivery Science, Biohaven, Click Therapeutics, Collegium, Eli Lilly, Ipsen, Linpharma, Lundbeck, Novartis, Satsuma, Scilex, Theranica, Tonix. Support for meeting attendance, Speech analyses for predicting migraine attacks. Predicting recovery patterns for TBI. Methods and processes for treatment migraine and post-traumatic headache. Patents, Investigator-initiated medication overuse headache clinical trial. Leadership, American Headache Society American Migraine Foundation. Stock Options: Aural Analytics, NociraM.S.: Speaker honoraria from Novartis, Pfizer, Allergan, Teva and Lilly.C.T.: For this manuscript, Institutional fees for conducting clinical trials for AbbVie, Dompé, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals. Consulting fees, AbbVie, Dompé, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals. Patents, AbbVie, Dompé, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals.A.T.: Received honoraria for lectures and speakers bureaus from AbbVie, Everpharma, Bial, Lusofarmaco, Zambon. Expert testimony, A.T. received support from Bial, AbbVie, Zambon. A.T. serves as associate Editor for the European Journal of Neurology.M.T.: received support from the European Headache Federation for accommodation and travel tickets to attend EHC 2022 as a scientific committee member. M.T. is the president of the Iranian Headache Association.G.V.: Honoraria from Lundbeck. Expert testimony, Teva and Lundbeck.S.J.W: For this manuscript received research grants from the National Council of Technology and Science of Taiwan, Brain Research Center, National Yang Ming Chiao Tung University from The Featured Areas Research Center Program within the framework of the Higher Education Sprout Project by the Ministry of Education (MOE) in Taiwan, Taipei Veterans General Hospital, Taiwan Headache Society and Taiwan branches of Eli Lilly and Novartis. Received honoraria as a moderator from AbbVie, Pfizer and Biogen. Served on the advisory boards of Taiwan Pfizer, AbbVie, Hava-Biopharma.M.A.: For this manuscript, Institutional grants from Lundbeck Foundation, Novo Nordisk Foundation, Lundbeck, and Novartis. In the past 24 months, MA has received personal compensation for consulting with AbbVie, AstraZeneca, Eli Lilly, GlaxoSmithKline, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals. Associate Editor of The Journal of Headache and Pain, Associate Editor of Brain.S.S.: For this manuscript, Novartis, Uriach. Royalties, Abbott, Allergan-AbbVie, AstraZeneca, Boheringer, Eli Lilly, Lundbeck, Novartis, NovoNordisk, Pfizer, Teva. Consulting fees, Abbott, Allergan-AbbVie, AstraZeneca, Boheringer, Eli Lilly, Lundbeck, MedScape, Novartis, NovoNordisk, Pfizer, Teva. Expert testimony, Abbott, Allergan-AbbVie, AstraZeneca, Boheringer, Eli Lilly, Lundbeck, Novartis, NovoNordisk, Pfizer, Teva, Bayer, Medtronic, Starmed, Bristol-Myers-Squibb, Daiichi-Sankyo. Patents, Allergan-AbbVie, AstraZeneca, Eli Lilly, Lundbeck, Novartis, Pfizer, Teva. Leadership, President-elect European Stroke Organization, Editor-in-Chief Cephalalgia and Cephalalgia Reports, assistant editor for Stroke.A.B., F.C., I.C., A.F., K.N.G., E.-M.H., M.H., A.Laporta, A.Lupica, I.O., L.-L.H.P., L.L.P., S.Q., M.R., D.B.S. have no conflict of interest to disclose

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