Accepted for Publication: March 27, 2021.
Published Online: June 7, 2021. doi:10.1001/jamaneurol.2021.1583
Corresponding Author: Kimford J. Meador, MD, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, 213 Quarry Rd, Mail Code 5979, Palo Alto, CA 94304 (firstname.lastname@example.org).
Author Contributions: Drs Meador and May had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Meador, Cohen, Loring, May, Brown, French, Pennell.
Acquisition, analysis, or interpretation of data: Meador, Cohen, May, Robalino, Matthews, Kalayjian, Gerard, Gedzelman, Penovich, Cavitt, Hwang, Sam, Pack, French, Tsai, Pennell.
Drafting of the manuscript: Meador, May, Brown, Robalino.
Critical revision of the manuscript for important intellectual content: Meador, Cohen, Loring, Brown, Robalino, Matthews, Kalayjian, Gerard, Gedzelman, Penovich, Cavitt, Hwang, Sam, Pack, French, Tsai, Pennell.
Statistical analysis: May, Brown, Robalino, Matthews, Tsai.
Obtained funding: Meador, Loring, Pennell.
Administrative, technical, or material support: Meador, Loring, Gerard, Pack, Pennell.
Supervision: Meador, May, Matthews, Gerard, Sam, Pack, Pennell.
Conflict of Interest Disclosures: Dr Meador reported receiving research support from the National Institutes of Health (NIH), Eisai Co, Ltd, and Sunovion Pharmaceuticals Inc; travel support from Eisai Co, Ltd; and consulting for Eisai Co, Ltd, GW Pharmaceuticals, NeuroPace, Novartis AG, Supernus Pharmaceuticals, Inc, Upsher-Smith Laboratories, LLC, UCB SA, and VIVUS Inc, with fees paid to the university by The Epilepsy Study Consortium. Dr Loring reports receiving support for research from the National Institute of Mental Health (NIMH) and National Institute of Neurological Disorders and Stroke (NINDS), consulting for NeuroPace, receiving editorial stipends from Epilepsia and Neuropsychology Review, and receiving book royalties from Oxford University Press. Dr Gerard reported receiving research support from Sage Therapeutics, Inc, Sunovion Pharmaceuticals Inc, and Xenon Pharmaceuticals Inc; speaker fees from GW Pharmaceuticals and UCB SA; and travel funds from UCB SA. Dr Penovich reported receiving support for advisory and speakers bureau for Neurelis, Inc, SK Biopharmaceuticals, and UCB SA, and for advisory work for LVIS Corporation and Engage Therapeutics, Inc. Dr Cavitt reported receiving research support from the NINDS (MONEAD) and from GW Pharmaceuticals. Dr Sam reported receiving advisory board consulting fees for Aquestive Therapeutics. Dr Pack reported receiving royalties for the website UpToDate. Dr French reported receiving salary support at New York University from the Epilepsy Foundation and for consulting work and/or attending on behalf of the Epilepsy Study Consortium for Adamas Pharmaceuticals, Inc, Aeonian/Aeovian, Anavex Life Sciences Corp, Arvelle Therapeutics, Athenen Therapeutics/Carnot Pharma, Axovant Sciences, Baergic Bio, Inc, Biogen Inc, Biomotiv/Koutif, BioXcel Therapeutics, Inc, Blackfynn, Bloom Science, Bridge Valley Ventures LLP, Cavion, Cerebral Therapeutics, Cerevel Therapeutics, Crossject, CuroNZ Limited, Eisai Co, Ltd, Eliem Therapeutics, Encoded Therapeutics, Engage Therapeutics, Inc, Engrail Therapeutics, Epiminder, Epitel, Inc, Fortress Biotech Inc, Greenwich Biosciences, GW Pharmaceuticals, Idorsia Pharmaceuticals Ltd, Ionis Inc, Janssen Global Services, LLC, Johnson & Johnson Services, Inc, Knopp Biosciences, H Lundbeck A/S, Marinus, Mend Neuroscience, Merck, NeuCyte, Inc, Neurelis, Inc, Neurocrine, Novartis AG, Otsuka Pharmaceutical Development, Ovid Therapeutics Inc, Passage Bio, Inc, Pfizer Inc, Praxis, Redpin Therapeutics, Inc, Sage Therapeutics, Inc, Shire plc, SK Life Sciences, Inc, Sofinnova, SpringWorks Therapeutics, Inc, Stoke Therapeutics, Sunovion Pharmaceuticals Inc, Supernus Pharmaceuticals, Inc, Takeda Pharmaceutical Company Limited, UCB SA, West Therapeutic Development, LLC, Xenon Pharmaceuticals Inc, Xeris Pharmaceuticals, Inc, Zogenix, Inc, and Zynerba Pharmaceuticals, Inc; receiving research grants from Biogen Inc, Cavion, Eisai Co, Ltd, Engage Therapeutics, Inc, GW Pharmaceuticals, H Lundbeck A/S, Neurelis, Inc, Ovid Therapeutics, Inc, Pfizer Inc, SK Life Sciences, Inc, Sunovion Pharmaceuticals Inc, UCB SA, Xenon Pharmceuticals Inc, Zogenix, Inc, the Epilepsy Research Foundation, the Epilepsy Study Consortium, and the NINDS; serving on the editorial board of Lancet Neurology and Neurology Today; serving as chief medical/innovation officer for the Epilepsy Foundation, for which New York University receives salary support; and receiving travel reimbursement related to research, advisory meetings, or presentation of results at scientific meetings from the Epilepsy Study Consortium, the Epilepsy Foundation, Adamas Pharmaceuticals, Inc, Arvelle Therapeutics, Inc, Axovant Sciences, Biogen Inc, Blackfynn, Cerevel Therapeutics, Crossject, CuroNZ Limited, Eisai Co, Ltd, Engage Therapeutics, Inc, Idorsia Pharmaceuticals Ltd, H Lundbeck A/S, NeuCyte, Inc, Neurelis, Inc, Novartis AG, Otsuka Pharmaceutical Development, Ovid Therapeutics Inc, Pfizer Inc, Redpin Therapeutics, Inc, Sage Therapeutics, SK Life Sciences, Inc, Sunovion Pharmaceuticals Inc, Takeda Pharmaceutical Company Limited, UCB SA, Xenon Pharmaceuticals Inc, and Zogenix, Inc. Dr Tsai reported receiving research support from the NIH, SK Life Sciences, Inc, and Xenon Pharmaceuticals Inc. Dr Pennell reported receiving grants from the NIH during the conduct of the study, personal fees from the NIH for grant reviews, personal fees from the American Epilepsy Society and the American Academy of Neurology as speaking honoraria, personal fees from Medical Schools for speaking honoraria and travel, and personal fees from UpToDate for royalties outside the submitted work. No other disclosures were reported.
Funding/Support: This work was supported by grants U01-NS038455 (Drs Meador and Pennell), U01-NS050659 (Dr May), and 2U01-NS038455 (Drs Meador, Pennell, and May) from the NINDS and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the NIH.
Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: A complete list of the members of the MONEAD Investigator Group appears in Supplement 2.
Additional Contributions: The investigators thank the children and families who have given their time to participate in the MONEAD Study. The authors thank the members of the MONEAD Investigator Group for their contributions.
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