TY - JOUR
T1 - Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults
AU - for the International Headache Society Clinical Trials Standing Committee
AU - Tassorelli, Cristina
AU - Diener, Hans Christoph
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
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:
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Cristina Tassorelli received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Allergan, Electrocore, Eli-Lilly, Novartis and Teva. Headache research at the IRCCS Mondino Foundation in Pavia is supported by the Italian Ministry of Health and the European Union. 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 the Clinical Trials Committee of the IHS.
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 NeurologÚa. 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.
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:
The Authors are grateful to Jay Mandrekar,?Professor of Biostatistics and Neurology?Director, Biostatistics Core, Mayo Clinic, for his qualified and precious assistance in the preparation of the paragraph on Statistics.
Publisher Copyright:
© 2018, © International Headache Society 2018.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Background: Quality clinical trials form 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. In 2008, the Committee published the first specific guidelines on chronic migraine. Subsequent advances in drug, device, and biologicals development, as well as novel trial designs, have created a need for a revision of the chronic migraine guidelines. Objective: The present update is intended to optimize the design of controlled trials of preventive treatment of chronic migraine in adults, and its recommendations do not apply to trials in children or adolescents.
AB - Background: Quality clinical trials form 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. In 2008, the Committee published the first specific guidelines on chronic migraine. Subsequent advances in drug, device, and biologicals development, as well as novel trial designs, have created a need for a revision of the chronic migraine guidelines. Objective: The present update is intended to optimize the design of controlled trials of preventive treatment of chronic migraine in adults, and its recommendations do not apply to trials in children or adolescents.
KW - Chronic migraine
KW - clinical trials
KW - drugs
KW - headache
KW - preventive treatment
UR - http://www.scopus.com/inward/record.url?scp=85043682418&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85043682418&partnerID=8YFLogxK
U2 - 10.1177/0333102418758283
DO - 10.1177/0333102418758283
M3 - Article
C2 - 29504482
AN - SCOPUS:85043682418
SN - 0333-1024
VL - 38
SP - 815
EP - 832
JO - Cephalalgia
JF - Cephalalgia
IS - 5
ER -