Inclusion and exclusion criteria for epilepsy clinical trials-recommendations from the April 30, 2011 NINDS workshop

Abstract

On April 30th, 2011 the National Institute of Neurological Disorders and Stroke (NINDS) held a workshop to identify key problems in recent epilepsy clinical trials and propose approaches to address the barriers that impede development of new therapeutic options for epilepsy. Preliminary recommendations were made for selection criteria for subjects entered into epilepsy trials that maximize the scientific impact of the trial and increase the ability to recruit appropriate subjects efficiently and safely. These recommendations were further refined by the authors following the workshop, and subsequently shared with all NINDS workshop participants and with the participants of the 2011 AED XI workshop on epilepsy trials (approximately 200 participants) for further comment. The working group agreed to a final set of criteria that include updated considerations of subject age, clinical semiology, EEG and imaging results, use of prior and current therapies, co-occurring conditions, and suicidality, among others.

Keywords: Clinical trial methodology; Comorbidity; Participant selection criteria; Recruitment.

Conflict of interest statement

Disclosure of Conflict of Interest

Evan Fertig is an employee of the Northeast Regional Epilepsy Group. He has received research support from Pfizer, UCB, Lundbeck, Vertex, Supernus, and Esai.

Brandy Fureman is an employee of the NINDS, NIH.

Gregory K. Bergey is an employee of the Johns Hopkins University School of Medicine.

Mary Ann Brodie is an employee of the Epilepsy Study Consortium. Within the past year, the Epilepsy Consortium has received funding for research support, meeting support and services provided from the following companies: Cyberonics, Eisai Medical Research, GlaxoSmithKline, Icagen, Inc., Johnson & Johnson, Marinus, Neurotherapeutics, NeuroVista Corporation, Ono Pharma USA, Inc., Lundbeck, Pfizer, Sepracor, Sunovion, SK Life Science, Supernus Pharmaceuticals, UCB Inc/Schwarz Pharma, Upsher Smith, Valeant, Vertex.

Dale C. Hesdorffer is an employee of GH Sergievsky Center and Department of Epidemiology, Columbia University. She has received travel funding from GlaxoSmithKline and the International League Against Epillepsy, and grant funding from the CDC, the NINDS, NICHD, the Epilepsy Study Consortium, and the Epilepsy Foundation of America.

Deborah Hirtz is an employee of the NINDS, NIH.

Eric H. Kossoff is an employee of the Johns Hopkins University School of Medicine.

W Curt LaFrance, Jr. is employed by Rhode Island Hospital. He has received grant support from NINDS, the American Epilepsy Society, the Epilepsy Foundation, Brown University and the Siravo Foundation. Dr. LaFrance receives book royalties for Gates and Rowan’s Nonepileptic Seizures, 3rd Edition, Cambridge University Press.

Mark Versavel is an employee of Sunovion Inc.

Jackie French serves as the president of The Epilepsy Study Consortium, a non-profit organization. NYU receives a fixed amount from the Epilepsy Study Consortium towards Dr. French’s salary. The money is for work performed by Dr. French on behalf of The Epilepsy Study Consortium, for consulting and clinical trial related activities. Dr French receives no personal income for these activities. Within the past year, The Epilepsy Study Consortium received payments from: Cyberonics, Eisai Medical Research, Entra Pharmaceuticals, GlaxoSmithKline, Icagen, Inc., Johnson & Johnson, Marinus, Neurotherapeutics, NeuroVista Corporation, Ono Pharma USA, Inc., Lundbeck, Pfizer, Sepracor, Sunovion, SK Life Science, Supernus Pharmaceuticals, UCB Inc./Schwarz Pharma, Upsher Smith, Valeant, Vertex.

Published by Elsevier B.V.