TY - JOUR
T1 - Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults
T2 - Fourth edition
AU - on behalf of the International Headache Society Clinical Trials Standing Committee
AU - Diener, Hans Christoph
AU - Tassorelli, Cristina
AU - Dodick, David W.
AU - Silberstein, Stephen D.
AU - Lipton, Richard B.
AU - Ashina, Messoud
AU - Becker, Werner J.
AU - Ferrari, Michel D.
AU - Goadsby, Peter J.
AU - Pozo-Rosich, Patricia
AU - Wang, Shuu Jiun
AU - Mandrekar, Jay
N1 - Funding Information:
Shuu-Jiun Wang has served on the advisory boards of Eli Lilly, Daiichi-Sankyo, and Taiwan Pfizer. He has received honoraria as a moderator from Allergan, Pfizer, Eli Lilly, Bayer, and Eisai. He has received research grants from the Taiwan Minister of Technology and Science, Brain Research Center of National Yang-Ming University, Taipei Veterans General Hospital, and Taiwan Headache Society.
Funding Information:
Michel D Ferrari reports grants and consultancy or industry support from Medtronic, Novartis, Lilly, TEVA, Amgen and Electrocore, and independent support from the European Community, NWO, NIH and the Dutch Heart & Brain Foundations.
Funding Information:
Cristina Tassorelli received honoraria for participation in clinical trials, contribution to advisory boards or scientific presentations from: Allergan, Electrocore, Eli-Lilly, Novartis, Teva and Medscape, LLC. CT has received independent support from the Italian Ministry of Health, Italian Ministry of Research and European Community. CT has no ownership interest and does not own stocks of any pharmaceutical company. CT serves as Chief Section Editor of Frontiers in Neurology – Section Headache Medicine and Facial Pain and on the editorial board of Journal of Headache and Pain. CT is the chairman of the Clinical Trials Committee of the IHS.
Funding Information:
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Hans-Christoph Diener has received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Alder, Allergan, Amgen, Autonomic Technology, Bristol-Myers Squibb, CoLucid, Electrocore, Ipsen, Lilly, Medtronic, MSD, Novartis, Pfizer, Schaper and Brümmer, Teva and Weber & Weber. Financial support for research projects was provided by Allergan, Electrocore, MSD and Pfizer. Headache research at the Department of Neurology in Essen is supported by the German Research Council (DFG), the German Ministry of Education and Research (BMBF) and the European Union. H.C. Diener has no ownership interest and does not own stocks of any pharmaceutical company. HCD serves on the editorial boards of Cephalalgia and Lancet Neurology. HCD chairs the Clinical Guidelines Committee of the German Society of Neurology and is member of the Clinical Trials Committee of the IHS.
Funding Information:
Richard B Lipton is the Edwin S. Lowe Professor of Neurology at the Albert Einstein College of Medicine in New York. He receives research support from the NIH: 2PO1 AG003949 (Program Director), 5U10 NS077308 (PI), 1RO1 AG042595 (Investigator), RO1 NS082432 (Investigator), K23 NS09610 (Mentor), K23AG049466 (Mentor). He also receives support from the Migraine Research Foundation and the National Headache Foundation. He serves on the editorial board of Neurology, senior advisor to Headache, and associate editor to Cephalalgia. He has reviewed for the NIA and NINDS, holds stock options in eNeura Therapeutics and Biohaven Holdings; serves as consultant, advisory board member, or has received honoraria from: American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, Vedanta. He receives royalties from Wolff’s Headache 7th and 8th Edition, Oxford Press University, 2009, Wiley and Informa.
Funding Information:
Patricia Pozo-Rosich has received honoraria as a consultant and speaker for: Allergan, Almirall, Chiesi, Eli Lilly, Janssen Cilag, MSD, Novartis and Teva. Her research group has received research grants from Allergan and has received funding for clinical trials from Alder, Boeringher Ingelheim, MSD, Electrocore, Eli Lilly, Janssen Cilag, Novartis. She is a trustee member of the board of the International Headache Society, she is the Coordinator of the Spanish Headache Study Group of the Spanish Neurological Society. She is in the editorial board of Revista de Neurologia. She is an editor for Frontiers of Neurology and Journal of Headache and Pain. 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. PPR does not own stocks from any pharmaceutical company. Jay Mandrekar has no conflicts of interest to report.
Publisher Copyright:
© International Headache Society 2019.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - The quality of clinical trials is an essential part of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for controlled trials of drugs in migraine. Scientific and clinical developments in headache medicine led to second and third editions in 2000 and 2012, respectively. The current, fourth edition of the Guidelines retains the structure and much content from previous editions. However, it also incorporates evidence from clinical trials published after the third edition as well as feedback from meetings with regulators, pharmaceutical and device manufacturers, and patient associations. Its final form reflects the collective expertise and judgement of the Committee. These updated recommendations and commentary are intended to meet the Society's continuing objective of providing a contemporary, standardized, and evidence-based approach to the conduct and reporting of randomised controlled trials for the acute treatment of migraine attacks.
AB - The quality of clinical trials is an essential part of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for controlled trials of drugs in migraine. Scientific and clinical developments in headache medicine led to second and third editions in 2000 and 2012, respectively. The current, fourth edition of the Guidelines retains the structure and much content from previous editions. However, it also incorporates evidence from clinical trials published after the third edition as well as feedback from meetings with regulators, pharmaceutical and device manufacturers, and patient associations. Its final form reflects the collective expertise and judgement of the Committee. These updated recommendations and commentary are intended to meet the Society's continuing objective of providing a contemporary, standardized, and evidence-based approach to the conduct and reporting of randomised controlled trials for the acute treatment of migraine attacks.
KW - Guidelines
KW - acute treatment of migraine attacks in adults
KW - controlled trials
UR - http://www.scopus.com/inward/record.url?scp=85062349317&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062349317&partnerID=8YFLogxK
U2 - 10.1177/0333102419828967
DO - 10.1177/0333102419828967
M3 - Article
C2 - 30806518
AN - SCOPUS:85062349317
VL - 39
SP - 687
EP - 710
JO - Cephalalgia
JF - Cephalalgia
SN - 0333-1024
IS - 6
ER -