The Pediatric Trials Network (PTN) has locked the database for Levetiracetam, one drug included in the Pharmacokinetics (PK) of Anti-epileptic Drugs in Obese Children (AED) study.
“With this study, the PTN and its sites have addressed the important, but under recognized problem of how obesity impacts drug pharmacokinetics in children. It can be hoped that the results will lead to improved anti-seizure medication use in overweight children, and subsequent reductions in seizure frequency,” said Susan Arnold, PTN site investigator and Director of the UT Southwestern Medical School Comprehensive Epilepsy Center.
Due to altered PK associated with obesity, dosing for anti-epileptics in children with obesity may vary from that in children without obesity. Inappropriate dosing may increase the risk for drug toxicity or therapeutic failure.
The AED study will enroll approximately 100 children, 2 to < 18 years of age, with a body mass index (BMI) > 95th percentile, who receive Levetiracetum, per standard of care. In addition to Levetiracetum, the AED study will also obtain PK data for Valproic Acid, Topiramate, and Oxcarbazepine.
As a next step, the PK data associated with Levetiracetum will be submitted to the FDA for potential drug label changes.