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August 07, 2012; 79 (6) Articles

Adjunctive perampanel for refractory partial-onset seizures

Randomized phase III study 304

Jacqueline A. French, Gregory L. Krauss, Victor Biton, David Squillacote, Haichen Yang, Antonio Laurenza, Dinesh Kumar, Michael A. Rogawski
First published July 25, 2012, DOI: https://doi.org/10.1212/WNL.0b013e3182635735
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Article Information

vol. 79 no. 6 589-596
DOI: 
https://doi.org/10.1212/WNL.0b013e3182635735
PubMed: 
22843280
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received December 19, 2011
  • Accepted March 28, 2012
  • First Published July 25, 2012.

Article Versions

Copyright & Usage: 
Copyright © 2012 by AAN Enterprises, Inc.

Author Disclosures

    1. Jacqueline A. French, MD,
    2. Gregory L. Krauss, MD,
    3. Victor Biton, MD,
    4. David Squillacote, MD,
    5. Haichen Yang, MD,
    6. Antonio Laurenza, MD,
    7. Dinesh Kumar, MS and
    8. Michael A. Rogawski, MD, PhD
  1. Jacqueline A. French, MD,
    2. Scientific Advisory Boards:

    1. Epilepsy Therapy Project; Eisai; UCB; Upsher-Smith; Sepracor; Vertex

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Paid travel to present findings at scientific meetings, present at investigators meetings attend advisory boards orgive lectures:; UCB; Eisai; Johnson and Johnson; Valeant; GlaxoSmithKline; Upsher- Smith; Pfizer; Novartis; Eli Lilly; Sepracor; Supernus; Vertex

    Editorial Boards:

    1. Epilepsy Currents, Associate Editor, 2009-2011; Epileptic Disorders, Supplement Editor; Lancet Neurology, Editorial Board, 2010-present; Neurotherapeutics, Editorial Board, 2010-present; Neurology Today, Editorial Board, 2010-present

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. President, Epilepsy Study Consortium, that recieves money from multiple pharmaceutical companies. I consult for a number of companies, on behalf of the Epilepsy Study consortium. A fixed 25% of my NYU salary is paid by the study consortium, and some of this money may come from consulting fees. Companies involved include GlaxoSmith Kline, Pfizer, UCB, Johnson & Johnson, Cyberonics, Schwarz Pharma, Ortho-McNeil, Eisai, Jazz Pharmaceuticals, Ovation Pharmaceuticals, Endo Pharmaceuticals, Bial Pharmaceuticals, Neurovista, Valeant Pharmaceuticals, Icagen, Supernus, SK Pharmaceuticals, Taro Pharmaceuticals, Neurotherapeutics, Sepracor, Novartis, Pfizer, Upsher-Smith, Vertex

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. PI on clinical trials for; Johnson & Johnson; Eisai; UCB; SK; Valeant; Upsher-Smith; Vertex; Pfizer

    Research Support, Government Entities:

    1. NIH 1 R01 NS053998-01A1, Coinvestigator, 2007-2011

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Epilepsy Research Foundation; The Milken Foundation Non-financial disclosures: President, Epilepsy Study Consortium

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. Gregory L. Krauss, MD,
    3. Scientific Advisory Boards:

    1. Epilepsy Study Consortium, Vice President; Lundbeck vigabatrin visual safety monitoring board (SHARE)

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Eisai Inc., airfare for presenting research at neurology meeting

    Editorial Boards:

    1. Epilepsy Currents, clinical science editor, 2010-2011

    Patents:

    1. NONE

    Publishing Royalties:

    1. The Johns Hopkins Digital EEG Atlas, JHU Press, 2006, 2011

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Vertex Laboratories; 2) Eisai Inc.

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. UCB Pharma, Principal Investigator, 2009-Present; Eisai Lab, Principal Investigator, 2009-Present; Sepracor Inc., Principal Investigator, 2009-Present; Vertex Inc., Principal Investigator, 2010-2011; Novartis, Principal Investigator, 2011

    Research Support, Government Entities:

    1. NIA, RC2AG036419, Principal Investigator, 2009-Present

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. The Epilepsy Research Foundation, Co-Principal Investigator, 2009-Present

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Victor Biton, MD,
    4. Scientific Advisory Boards:

    1. Dec 2010 - Eisai regarding E2007 Jan 2011 - Lundbeck regarding Clobazam June 2011 - Upsher-Smith

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Dec 2010 - Eisai regarding E2007 Jan 2011 - Lundbeck regarding Clobazam June 2011 - Upsher-Smith

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. Clinical Trials, Inc. - Private Research facility/PI E2007-G000-304/307 (2008-2011) E2007-A01-206/207 (2005-2007)

    Research Support, Commercial Entities:

    1. Victor Biton, MD is currently an investigator for Eisai, Janssen, King, Medivation, Pfizer, Sepracor/Sunovion, UCB/Schwarz, Depomed, Lundbeck, Schering-Plough/Merck, Upsher-Smith, SK Life Sciences, Daiichi Sankyo, Vertex and Wyeth. Dr. Biton has been an investigator for Xenoport, Medivation, Dainippon, GSK, Genzyme, Astellas/Fujisawa, Myriad, RWJPRI, Insmed, Ortho McNeil, Jazz, Carter Wallace/MedPointe, Parke-Davis, HMR/Sanofi-Aventis, Novartis, IVAX, Abbott, AstraZeneca, Cyberonics, , Schwabe, SkyePharma, NPS, Saegis, Eunoe, Genentech, Abbott, J&J, Marinus, Intranasal/Ikano, Ovation/Lundbeck, Schwarz/UCB, Valeant, XTL, Forest, Elan, Icagen, Impax and Vernalis.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. David Squillacote, MD,
    5. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Eisai Inc.

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Haichen Yang, MD,
    6. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Eisai Inc., Senior Director

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Antonio Laurenza, MD,
    7. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Eisai, Inc., Executive Director, Clinical Development

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Dinesh Kumar, MS and
    8. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. Employed by Eisai Inc

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Michael A. Rogawski, MD, PhD
    9. Scientific Advisory Boards:

    1. Gilead Sciences Novartis Pharma Teva Pharmaceuticals

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. GlaxoSmithKline UCB

    Editorial Boards:

    1. BMC Pharmacology, editorial board, 2001–present Cellular and Molecular Neurobiology, editorial board, 1988–present Molecular Pharmacology, editorial advisory board, 1994– present Neurotherapeutics, associate editor, 2005-present Scientific Reports, editorial board, 2011–present The Open Pharmacology Journal, editorial advisory board, 2008–present The Scientific World Journal: Pharmacology Domain, editorial board, 2011–present

    Patents:

    1. Treatment for epilepsy; Formulation of neurosteroids

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Eisai Eli Lilly & Co. Ono Pharmaceuticals USA Sepracor SK Life Sciences Upsher-Smith

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Eisai Gilead Sciences

    Research Support, Government Entities:

    1. Congressionally Directed Medical Research Programs, DR081314, principal investigator, 2009-present Congressionally Directed Medical Research Programs, DR081314, co-principal investigator, 2011-present National Institutes of Health, NS072094, principal investigator, 2010-present National Institutes of Health, RR024146, principal investigator, 2012

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Epilepsy Research Foundation People Against Childhood Epilepsy

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Marinus Pharmaceuticals, 2004 MedGenesis Therapeutix, 2008

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

                                                                                                                                                          1. From the NYU Comprehensive Epilepsy Center (J.A.F.), New York, NY; Johns Hopkins University (G.L.K.), Baltimore, MD; Arkansas Epilepsy Program (V.B.), Little Rock; Eisai Inc. (D.S., H.Y., A.L., D.K.), Woodcliff Lake, NJ; and Department of Neurology (M.A.R.), School of Medicine and Center for Neuroscience, University of California, Sacramento.
                                                                                                                                                          1. Hospital General de Agudos “Dr. Teodoro Alvarez, Buenos Aires, Principal Investigator
                                                                                                                                                          1. Hospital Privado Santa Clara de Asis, Salta, Principal Investigator
                                                                                                                                                          1. FundaciónF.a.i.c.e.p, Buenos Aires, Principal Investigator
                                                                                                                                                          1. Hospital General de Agudos Dr. Jose Maria Ramos Mejia, Ciudad Autonoma de Buenos Aires, Principal Investigator
                                                                                                                                                          1. Hospital Britanico de Buenos Aires, Ciudad Autonoma de Buenos Aires, Principal Investigator
                                                                                                                                                          1. Centro para el estudio y tratamiento de la epilepsia y sueño, Córdoba, Principal Investigator
                                                                                                                                                          1. Fundación Para la Lucha Contra lasEnfermedadesNeurológicas de la Infancia, Capital Federal, Principal Investigator
                                                                                                                                                          1. Hospital San Roque, Córdoba, Principal Investigator
                                                                                                                                                          1. InstitutoGinecologico Lanus Oeste, Buenos Aires IGBA, Lanus Oeste, Buenos Aires, Principal Investigator
                                                                                                                                                          1. FundaciónCerebro y Mente, Guaymallen, Principal Investigator
                                                                                                                                                          1. Centro Mulieris, Ciudad Autonoma de Buenos Aires, Principal Investigator
                                                                                                                                                          1. NeurologiaInfantil Buenos Aires - NIBA, Ciudad Autonoma de Buenos Aires, Principal Investigator
                                                                                                                                                          1. Centro Regional Integral de Neurociencias, Tucuman, Principal Investigator
                                                                                                                                                          1. Hogar de Dia Casa Jesi, La Plata, Buenos Aires, Principal Investigator
                                                                                                                                                          1. Neuro Rive-Sud, Greenfield Park, Principal Investigator
                                                                                                                                                          1. Youthdale Treatment Centres, Toronto, Principal Investigator
                                                                                                                                                          1. London Health Science Center, London, Principal Investigator
                                                                                                                                                          1. Foothills Medical Centre, Calgary, Principal Investigator
                                                                                                                                                          1. Sociedad Lasso y Bittner LtdaNeuropsicología, Santiago, Principal Investigator
                                                                                                                                                          1. Hospital Dr. Sotero del Rio, Santiago, Principal Investigator
                                                                                                                                                          1. Hospital de Valdivia, Valdivia, Principal Investigator
                                                                                                                                                          1. Hospital Barros Luco Trudeau, Santiago, Principal Investigator
                                                                                                                                                          1. Médica Sur, S.A.B. de C.V., Mexico City, Distrito Federal, Principal Investigator
                                                                                                                                                          1. Hospital y Clinica OCA, SociedadAnónima de Capital Variable, Monterrey, Nuevo León, Principal Investigator
                                                                                                                                                          1. InstitutoBiomédico de Investigación A.C., Aguascalientes, Principal Investigator
                                                                                                                                                          1. Hospital Central Dr. Ignacio MoronesPrieto, San Luis Potosi, Principal Investigator
                                                                                                                                                          1. Long Island Jewish Medical Center C/O Brany, New Hyde Park, Principal Investigator
                                                                                                                                                          1. Texas Children's Hospital, Houston, Principal Investigator
                                                                                                                                                          1. Louisiana State University Health Sciences Center, Shreveport, Principal Investigator
                                                                                                                                                          1. Northwest Florida Clinical Research Group, LLC, Gulf Breeze, Principal Investigator
                                                                                                                                                          1. McFarland Clinic, P.C., Ames, Principal Investigator
                                                                                                                                                          1. Children's Healthcare of Atlanta, Atlanta, Principal Investigator
                                                                                                                                                          1. Mile High Research Center, Denver, Principal Investigator
                                                                                                                                                          1. University Neurology, Cincinnati, Principal Investigator
                                                                                                                                                          1. Virginia Commonwealth University, Richmond, Principal Investigator
                                                                                                                                                          1. Medical University of South Carolina, Charleston, Principal Investigator
                                                                                                                                                          1. Pediatric Epilepsy And Neurology Specialists, Tampa, Principal Investigator
                                                                                                                                                          1. Via Christi Comprehensive Epilepsy Center, Wichita, Principal Investigator
                                                                                                                                                          1. Thomas Jefferson University, Philadelphia, Principal Investigator
                                                                                                                                                          1. Midatlantic Epilepsy and Sleep Center, Bethesda, Principal Investigator
                                                                                                                                                          1. Tallahassee Neurological Clinic, Tallahassee, Principal Investigator
                                                                                                                                                          1. Texas Tech University Health Sciences Center, El Paso, Principal Investigator
                                                                                                                                                          1. Neurological Clinic of Texas,Dallas, Principal Investigator
                                                                                                                                                          1. Pediatric Neurology, P.A., Orlando, Principal Investigator
                                                                                                                                                          1. Dallas Pediatric Neurology Associates, Dallas, Principal Investigator
                                                                                                                                                          1. Children's Medical Center Hospital of Akron, Akron, Principal Investigator
                                                                                                                                                          1. Regional Epilepsy Center, Milwaukee, Principal Investigator
                                                                                                                                                          1. University of Louisville, Louisville, Principal Investigator
                                                                                                                                                          1. UW Regional Epilepsy Center, Seattle, Principal Investigator
                                                                                                                                                          1. The Ohio State University, Columbus, Principal Investigator
                                                                                                                                                          1. University of Florida Health Science Center-Jacksonville, Jacksonville, Principal Investigator
                                                                                                                                                          1. St. Joseph's Hospital Medical Center, Phoenix, Principal Investigator
                                                                                                                                                          1. Georgia Neurology and Sleep Medicine Associates, Suwanee, Principal Investigator
                                                                                                                                                          1. Five Towns Neurology, PC, Cedarhurst, Principal Investigator
                                                                                                                                                          1. Neurological Associates Of Tulsa, Inc., Tulsa, Principal Investigator
                                                                                                                                                          1. Asheville Neurology Specialists, PA, Asheville, Asheville, Principal Investigator
                                                                                                                                                          1. Clinical Trials Inc, Little Rock, Principal Investigator
                                                                                                                                                          1. John Hopkins Hospital, Baltimore, Principal Investigator
                                                                                                                                                          1. Childrens Hospital Los Angeles, Los Angeles, Principal Investigator
                                                                                                                                                          1. Washington University,St. Louis, Principal Investigator
                                                                                                                                                          1. University of Alabama at Birmingham, Birmingham, Principal Investigator
                                                                                                                                                          1. University of Tennessee LeBonheurChildrens Medical Center, Memphis, Principal Investigator
                                                                                                                                                          1. Lovelace Scientific Resources, Sarasota, Principal Investigator
                                                                                                                                                          1. University of Toledo Medical Center, Toledo, Principal Investigator
                                                                                                                                                          1. Children's Hospital of Philadelphia, Philadelphia, Principal Investigator
                                                                                                                                                          1. Albany Medical College, Albany, Principal Investigator, Principal Investigator
                                                                                                                                                          1. University of Alabama at Birmingham, Birmingham, Principal Investigator
                                                                                                                                                          1. LSU Hospital, Houma, Principal Investigator
                                                                                                                                                          1. Children's National Medical Center, Washington, Principal Investigator
                                                                                                                                                          1. University of Kentucky Research Foundation, Lexington, Principal Investigator
                                                                                                                                                          1. Providence St. Vincent's Epilepsy Center, Portland, Principal Investigator
                                                                                                                                                          1. Josephson WallackMunshower Neurology, PC, Indianapolis, Principal Investigator
                                                                                                                                                          1. Strong Memorial Hospital, Rochester, Principal Investigator
                                                                                                                                                          1. University of Texas Southwestern Medical Center, Dallas, Principal Investigator
                                                                                                                                                          1. Bright Minds Institute, San Francisco, Principal Investigator
                                                                                                                                                          1. California Pacific Medical Center, San Francisco, Principal Investigator.
                                                                                                                                                          1. Correspondence & reprint requests to Dr. French: Jacqueline.French{at}nyumc.org
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