Inclusion and exclusion criteria for epilepsy clinical trials-recommendations from the April 30, 2011 NINDS workshop.
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.
Northeast Regional Epilepsy Group, Hackensack, NJ, United States.
Evan
E
Fertig
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United States. Electronic address: furemanb@ninds.nih.gov.
Brandy E
BE
Fureman
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Gregory K
GK
Bergey
The Epilepsy Study Consortium, New York City, NY, United States.
Mary Ann
MA
Brodie
Department of Epidemiology, Columbia University, New York, NY, United States.
Dale C
DC
Hesdorffer
National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United States.
Deborah
D
Hirtz
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Eric H
EH
Kossoff
Departments of Psychiatry and Neurology (Research), Brown Medical School, Rhode Island Hospital, Providence, RI, United States.
W Curt
WC
LaFrance
Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.
Mark
M
Versavel
The Epilepsy Study Consortium, New York City, NY, United States; Department of Neurology, New York University, New York City, NY, United States.
Jacqueline
J
French
D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D004351:Drug Resistance; D004569:Electroencephalography; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D055825:National Institute of Neurological Disorders and Stroke (U.S.); D018579:Patient Selection; D012640:Seizures / Q000188:drug therapy / Q000503:physiopathology; D014481:United States
D000927:Anticonvulsants
Clinical trial methodology; Comorbidity; Participant selection criteria; Recruitment