Abstracts

To identify situations where equipoise (uncertainty) exists regarding initiation of AED therapy after two unprovoked seizures in children. This has implications for design of future placebo-controlled trials for anti-epileptic drug (AED) monotherapy in children., A survey with ten case scenarios of new-onset epilepsy in children was developed. Features varying across scenarios included: age, seizure semiology, seizure duration, post-ictal state, time between seizures, time since last seizure, EEG and MRI results, and patient comorbidities. The survey was administered to Pediatric health care providers (HCPs). Survey participants were asked two questions about each case: 1) [ldquo]Initiation of a daily AED is indicated[rdquo] [ndash] answered using a 5 point Likert scale; and 2) [ldquo]I would consider referring this patient for a clinical trial comparing a standard AED with placebo[rdquo] [ndash] answered as yes/no., To date, 151 HCPs completed the survey. Among the 38 HCPs who identified themselves as Pediatric Neurology or Developmental Pediatrics, 13% to 71% responded they disagreed or were uncertain regarding the need to begin an AED. Among the 113 responders who identified themselves as General Pediatrics, Subspecialty Pediatrics or Adult Neurology, 15% to 74% responded they disagreed or were uncertain regarding the need to begin an AED. Features correlating most strongly with desire to initiate an AED (up to 85% of all participants) included abnormal MRI or EEG results, convulsions, and older age. Seizure duration, post-ictal state, time interval between seizures, time interval since the last seizure, and patient comorbidities did not correlate with desire to start an AED. With regard to referral for a placebo-controlled trial, 35-78% of Peds Neuro/Dev Peds respondents were willing to refer, compared to 34-59% of other respondents., Given certain clinical features, equipoise exists regarding the initiation of AED therapy after two unprovoked seizures in children. Placebo-controlled trials are ethical and possible in children with new-onset epilepsy if inclusion criteria based on equipoise are carefully crafted., (Supported by a grant from the Child Neurology Foundation to Meera Gupta.)