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Cognitive antiepileptic drug (AED) outcomes in pediatric localization-related epilepsy (COPE)
Investigator (PI): Loring, David
Performing Organization (PO): (Current): Emory University, School of Medicine, Department of Neurology / (404) 727-3735
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2015
Record Source/Award ID: PCORI/527
Funding: Total Award Amount: $2,071,577
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Number of Subjects: 300
Abstract: 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 upon 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 since children are 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 only for school achievement, but also for longer term outcomes including subsequent employment and vocational options. This study will determine changes in cognitive abilities (e.g., 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 6-12 years of age will be randomized to levetiracetam, lamotrigine, or oxcarbazepine. There will be 12 study sites throughout the US. Children will be studied using tests of cognition that are well-validated before taking medications, and again following 3 and 6 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 upon 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.
MeSH Terms:
  • Anticonvulsants /adverse effects
  • /*therapeutic use
  • Attention /drug effects
  • Child
  • Cognition /drug effects
  • Cognition Disorders /complications
  • /prevention & control
  • Epilepsy /complications
  • /*drug therapy
  • Humans
  • Memory /drug effects
  • Multicenter Studies as Topic
  • Outcome Assessment, Health Care
  • Randomized Controlled Trials as Topic
  • Risk
  • Seizures /prevention & control
  • United States
  • Vulnerable Populations
Country: United States
State: Georgia
Zip Code: 30322
UI: 20143341
CTgovId: NCT01891890
Project Status: Completed
Record History: ('Project shortened from Final Year 2016 to 2015, 11/16/17.',)