Trial name or title | Cognitive AED outcomes in pediatric localization related epilepsy (COPE) |
Methods | Phase 3 randomised, single‐blinded (outcome assessor) trial conducted at 12 sites in the USA 3 treatment arms: LEV, LTG and OXC |
Participants | Children aged 5‐16 at the time of enrolment with localisation‐related partial epilepsy with or without secondary generalised Participants must be AED naive or have had less than a weeks' exposure to AEDs Estimated enrolment = 300 |
Interventions | Monotherapy with LEV, LTG or OXC Assessments made at 3 and 6 months |
Outcomes | Conners' Continuous Performance Test (CPT) Confidence Interval Child Behavior Checklist Weschler Intelligence Scale for Children‐IV Processing Speed Story Memory Symbol Digit Modalities Test Grooved Pegboard Columbia Suicidality Severity Rating Scale Youth Self Report Affective Reactivity Scale Pediatric Neuro‐QOL Parenting Stress Index Pediatric Inventory for Parents |
Starting date | August 2013 |
Contact information | Emory University |
Notes | Trial registered as NCT01891890 on ClincalTrials.gov and listed as ongoing but not recruiting participants (correct to August 2016). Estimated finishing date is April 2017. |