Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

*This project was terminated due to issues relating to recruitment.

Epilepsy is the most common serious chronic neurological disease in childhood, and localization related epilepsy (LRE) is the largest pediatric epilepsy group in aggregate. Treatment of children with epilepsy involves medications designed to stop their seizures, although all epilepsy medications may have adverse side effects on cognition that can reduce attention, processing speed, and memory. The risk of detrimental long-term medication effects on cognitive abilities is a major concern for parents. Although the medications used to treat pediatric LRE do not differ in their ability to control seizures, they likely have different effects on cognition. However, there have been no studies of possible differential treatment effects on cognition in pediatric LRE, and medications are selected based on non-scientific biases of the treating physician without full understanding of potential treatment effects on cognition.

Children with LRE represent a particularly vulnerable population for treatment related cognitive side effects because they are still developing cognitively and socially. Negative treatment effects on cognition can diminish developmental outcomes. If medication differences in the amount of cognitive side effect risk exist, then selecting treatments associated with poorer cognitive outcome needlessly interferes with cognitive development and school performance. Choosing a medication with the least cognitive impairment will maximally preserve cognitive abilities, which not only has implications for school achievement, but also for longer term outcomes, including subsequent employment and vocational options.

This study will determine changes in cognitive abilities (eg, attention) associated with three of the most common medications used to treat pediatric LRE. Children who are newly diagnosed with LRE by their treating physicians and are between 6 and 12 years of age will be randomized to levetiracetam, lamotrigine, or oxcarbazepine. There will be 12 study sites throughout the United States. Children will be studied using well-validated tests of cognition before taking medications and again following three and six months of treatment when they visit their physician for routine medical care. Because the doctors and families will know what drug is being used, attention will be studied using a computerized test, and other performance measures will be obtained by a blinded assessor. If attentional differences between drugs are seen, then anti-epilepsy medications can be selected with the least detrimental cognitive effects. If no differences are seen, treatments can be selected based on other factors, such as cost.

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.