TY - JOUR
T1 - Proposal for an updated seizure classification framework in clinical trials
AU - Steriade, Claude
AU - Sperling, Michael R.
AU - DiVentura, Bree
AU - Lozano, Meryl
AU - Shellhaas, Renée A.
AU - Kessler, Sudha Kilaru
AU - Dlugos, Dennis
AU - French, Jacqueline
N1 - Funding Information:
C.S. receives New York University (NYU) salary support for consulting work on behalf of the Epilepsy Study Consortium for Baergicm, Biogen, BioXcel, Cerebral, Cerevel, Engage, Janssen, NeuCyte, Neurocrine, and SK Life Science. C.S. receives research support from Finding a Cure for Epilepsy and Seizures (FACES), the NYU Clinical Translational Science Institute Scholars Program, the National Organization for Rare Diseases, and the Dorris Duke Fund to Retain Clinician Scientists. She is an investigator on research grants awarded to NYU from Cerevel and Xenon. M.R.S. has received compensation for speaking at continuing medical education (CME) programs from Neurology Live, Medscape, Projects for Knowledge, International Medical Press, Eisai, and UCB Pharma. He is an advisor for scientific publications for Neurelis. He consults for Medtronic with payments to Thomas Jefferson University. He has received research support from Eisai, Medtronic, Neurelis, SK Life Science, Takeda, Xenon, Cerevel, UCB Pharma, and Engage Pharmaceuticals. He has received royalties from Oxford University Press. B.D. and M.L. are employees of the Epilepsy Study Consortium, which has received research and meeting support from and has provided consulting services to Acadia, Aeovian, Alterity Therapeutics, Anavex, Arkin Holdings, Arvelle Therapeutics, Athenen Therapeutics, Baergic Bio, Biogen, BioXcel Therapeutics, Cerebral Therapeutics, Cerevel, Corlieve Therapeutics, Crossject, Eisai, Eliem Therapeutics, Encoded Therapeutics, Engage Therapeutics, Engrail, Epalex, Epihunter, Epiminder, Equilibre BioPharmaceuticals, Fortress Biotech, Greenwich Biosciences, GW Pharma, Janssen Pharmaceutica, Knopp Biosciences, LivaNova, Longboard Pharmaceuticals, Lundbeck, Marinus, Medtronic, Mend Neuroscience, Merck, NeuCyte, Neurocrine, Neuropace, Otsuka Pharmaceutical Development, Ovid Therapeutics, Passage Bio, Praxis, PrevEp, PureTech LYT, Sage, SK Life Science, Sofinnova, Stoke, Sunovion, Supernus, Synergia Medical, Takeda, UCB, Xenon Pharmaceuticals, Xeris, Zogenix, and Zynerba. R.A.S. receives research support from the National Institutes of Health (NIH), the Patient‐Centered Outcomes Research Institute, the Pediatric Epilepsy Research Foundation, and the University of Michigan. She receives honoraria from UpToDate for authorship on topics related to neonatal seizures, serves as a consultant for the Epilepsy Study Consortium, and is an associate editor for . S.K.K. is an investigator on research grants awarded to Children's Hospital of Philadelphia from Acadia, Eisai, SK Life Science, UCB, Zogenix, and Neuropace. D.D. receives salary support from the NIH, Commonwealth of Pennsylvania Department of Health, Pediatric Epilepsy Research Foundation, and Epilepsy Study Consortium. He is an investigator on research grants awarded to Children's Hospital of Philadelphia from Ovid/Takeda, Zogenix, Greenwich Biosciences, Neurelis, Bio‐Pharm, SK Life Science, and Encoded Therapeutics. He has received travel expenses for protocol development conferences or investigator meetings from Marinus, Ovid/Takeda, Biogen, Zogenix, and Xenon. He has received honoraria and/or travel support for CME and other educational programs from Wake Forest University School of Medicine and the American Epilepsy Society. J.F. receives NYU salary support from the Epilepsy Foundation and for consulting work and/or attending scientific advisory boards on behalf of the Epilepsy Study Consortium for Adamas, Aeonian/Aeovian, Alterity Therapeutics, Anavex, Arkin Holdings, Arvelle Therapeutics, Athenen Therapeutics/Carnot Pharma, Baergic Bio, Biogen, BioXcel Therapeutics, Cavion, Cerebral Therapeutics, Cerevel, Corlieve Therapeutics, Crossject, CuroNZ, Eisai, Eliem Therapeutics, Encoded Therapeutics, Engage Therapeutics, Engrail, Epalex, Epihunter, Epiminder, Equilibre BioPharmaceuticals, Fortress Biotech, Greenwich Biosciences, GW Pharma, Janssen Pharmaceutica, Knopp Biosciences, LivaNova, Longboard Pharmaceuticals, Lundbeck, Marinus, Mend Neuroscience, Merck, NeuCyte, Neurocrine, Neuropace, Otsuka Pharmaceutical Development, Ovid Therapeutics, Passage Bio, Praxis, PureTech LTY, Redpin, Sage, SK Life Science, Sofinnova, Stoke, Supernus, Synergia Medical, Takeda, UCB, West Therapeutic Development, Xenon, Xeris, Zogenix, and Zynerba. J.F. has also received research support from the Epilepsy Study Consortium (funded by the Andrews Foundation, Eisai, Engage, Lundbeck, Pfizer, SK Life Science, Sunovion, UCB, and Vogelstein Foundation), the Epilepsy Study Consortium/Epilepsy Foundation (funded by UCB), GW Pharmaceuticals/FACES, and the National Institute of Neurological Disorders and Stroke. She is on the editorial board of and . She is Chief Medical/Innovation Officer for the Epilepsy Foundation, for which NYU receives salary support. She has received travel reimbursement related to research, advisory meetings, or presentation of results at scientific meetings from the Epilepsy Study Consortium, the Epilepsy Foundation, Arvelle Therapeutics, Biogen, Cerevel, Engage, Lundbeck, NeuCyte, Otsuka, Sage, UCB, Xenon, and Zogenix. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. Neurology Lancet Neurology Neurology Today
Publisher Copyright:
© 2022 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.
PY - 2022/3
Y1 - 2022/3
N2 - The International League Against Epilepsy (ILAE) seizure classification scheme has been periodically updated to improve its reliability and applicability to clinicians and researchers alike. Here, members of the Epilepsy Study Consortium propose a pragmatic seizure classification, based on the ILAE scheme, designed for use in clinical trials with a focus on outcome measures that have high reliability, broad interpretability across stakeholders, and clinical relevance in the context of the development of novel antiseizure medications. Controversies around the current ILAE classification scheme are discussed in the context of clinical trials, and pragmatic simplifications to the existing scheme are proposed, for intended use by investigators, industry sponsors, and regulatory agencies.
AB - The International League Against Epilepsy (ILAE) seizure classification scheme has been periodically updated to improve its reliability and applicability to clinicians and researchers alike. Here, members of the Epilepsy Study Consortium propose a pragmatic seizure classification, based on the ILAE scheme, designed for use in clinical trials with a focus on outcome measures that have high reliability, broad interpretability across stakeholders, and clinical relevance in the context of the development of novel antiseizure medications. Controversies around the current ILAE classification scheme are discussed in the context of clinical trials, and pragmatic simplifications to the existing scheme are proposed, for intended use by investigators, industry sponsors, and regulatory agencies.
KW - classification
KW - clinical trials
KW - epilepsy
UR - http://www.scopus.com/inward/record.url?scp=85122578963&partnerID=8YFLogxK
U2 - 10.1111/epi.17120
DO - 10.1111/epi.17120
M3 - Article
C2 - 34997581
AN - SCOPUS:85122578963
SN - 0013-9580
VL - 63
SP - 565
EP - 572
JO - Epilepsia
JF - Epilepsia
IS - 3
ER -