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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
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.