Neurodevelopmental Effects of Antiepileptic Drugs (NEAD)
Researchers want to determine what impact carbamazepine (TegretolR, Tegretol-XRR, CarbatrolR), lamotrigine (LamictalR), phenytoin (DilantinR), and valproate (DepakoteR) have on the children’s ability to think and learn.
Three hundred and thirty women and their children in the US and England taking one of the four most commonly prescribed anti-seizure medications. The mothers and children are followed from their first trimester until their children are several years old.
The primary objective of the NEAD study is to differentiate the relative risks and benefits of the 4 most commonly used AEDs (Carbamazepine, lamotrigine, phenytoin, or valproate) in women of childbearing age in terms of their children’s neurobehavioral outcomes. It is a prospective, parallel-group, cohort design, multi-center study, which has enrolled 4 groups of pregnant women with epilepsy on AED monotherapy. The results of the NEAD study will improve the health of the children of women taking AEDs and have important applications to the future treatments of women in childbearing age. The specific aims of the Data and Statistical Center (DSC) are to support the coordination of study activities, facilitate data collection through an internet-based data system, and provide statistical and data analysis support in reporting study results.