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Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study
The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?
This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
University of Alabama
Birmingham, Alabama, United States
Arizona Health Sciences
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
RUSH University Medical Center
Chicago, Illinois, United States
Via Christi Medical Center
Wichita, Kansas, United States
Brigham & Womens' Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Start Date
September 1, 2000
Primary Completion Date
August 1, 2010
Completion Date
August 1, 2012
Last Updated
November 11, 2013
331
ACTUAL participants
Differential Abilities Scale
BEHAVIORAL
Neuropsychological Testing
BEHAVIORAL
Lead Sponsor
Emory University
Collaborators
NCT06700356
NCT05077904
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05667142