Yale University is a key member of a nationwide group of medical centers awarded a $17 million grant from the National Institute of Neurologic Disorders and Stroke, a division of the National Institutes of Health, for a study of childhood absence (petit mal) epilepsy.
The grant funds a head-to-head trial of the three most commonly used anti-epileptic drugs for absence seizures, which account for 10 to 15 percent of all cases of epilepsy in children. The goal is to determine the best initial medicine for childhood absence epilepsy, which involves seizures marked by non-convulsive staring spells.
The five-year study will enroll 439 children, ages two to 13, at 20 sites across the country. Yale University is a test site through the General Clinical Research Center at Yale-New Haven Hospital. The grant is the largest ever for a pediatric epilepsy study, and the clinical trial will be the largest head-to-head drug trial ever conducted for pediatric epilepsy, according to study investigators Edward J Novotny, Jr., M.D., and Susan Levy, M.D. of the Pediatric Epilepsy Program at Yale University School of Medicine.
In addition to the clinical trial, the grant funds pharmacokinetic and pharmacogenetic research on how these medicines act in children with childhood absence epilepsy. Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes drugs. Pharmacogenetics is the study of genetic determinants of the response to drugs.
The Yale investigators seek to identify the factors underlying individual variations in the success of treatments-why some have side effects and others don't-and the effects on cognition, behavior and learning. "This is the first step toward our goal of making it possible for physicians to predict patient response and tailor therapies for individual needs," said Novotny, who is a physician in the Departments of Pediatrics, Neurology and Neurosurgery at Yale School of Medicine.
The Pediatric Epilepsy program is part of the multidisciplinary Epilepsy Program at Yale. Several clinical and basic science research programs are a part of this internationally renowned center. Children with epilepsy are involved in many studies including the Connecticut Childhood Epilepsy study, outcome of epilepsy surgery and advanced neuroimaging investigations in epilepsy. Novotny said this project is an important addition to these clinical investigations.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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