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

- Adequate selection and enrollment of subjects are key to successful epilepsy trials.
- Selection criteria must maximize scientific impact, safety, and ability to recruit.
- Workshop attendees suggested guidelines for “default” criteria for epilepsy trials.
- Criteria apply to regulatory trials in subjects with focal or generalized seizures.

SummaryOn 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.