drugset / Trial / NCT01891890

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

NCT01891890

RandomizedParallel-groupSingle-blindTreatment

Summary

Seizures that arise in specific areas in the brain are called Localization Related Epilepsy (LRE) and are the most common seizure disorder in children. Children that receive drug treatment for this disorder may suffer from treatment related side effects which impact their ability to think or concentrate and their ability to interact socially. These negative treatment effects can impact the child's performance in school and long term may impact employment and job options. This study will determine whether changes in attention and social interactions are seen in children treated for LRE using three of the most common medications used to treat pediatric LRE. Children who are newly diagnosed with LRE by their doctors and are between the ages of 5 years 6 months and 16 years 0 months will be randomized to receive levetiracetam, lamotrigine, or oxcarbazepine. There will be 14 study sites throughout the US. Children will undergo evaluation of their thinking and ability to pay attention before and after starting drug treatment for LRE. Regardless of the specific findings, results of this study will provide the information needed to help parents and their clinicians choose treatment options that maximize cognitive abilities in children with LRE, and provide the data needed for practice guidelines to be established on the basis of cognitive side effect risks.

Timeline

Start
2013-08
Primary completion
2015-10-23
Completion
2015-10-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lamotrigine Small molecule 7 mg/kg
Comparator Levetiracetam Other / unclassified 30 mg/kg
Comparator Oxcarbazepine Small molecule 25 mg/kg

Indications