Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Seizure; Cognition Disorders
Intervention: Differential Abilities Scale (Behavioral); Neuropsychological Testing (Behavioral)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Florida Official(s) and/or principal investigator(s):
Kimford J. Meador, M.D., Principal Investigator, Affiliation: University of Florida
Summary
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?
Clinical Details
Official title: Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study
Study design: Family-Based, Prospective
Primary outcome: Child IQ as measured by the Differential Abilities Scale at 6 Years of age
Secondary outcome: Executive Functioning,Tower-NEPSYLinguistic Functioning via Expressive one word vocabulary test and NEPSY subscales Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale Memory via Children's Memory Scale Motor Functioning via Grooved Pegboard Academic Functioning via Wide Range Achievement Test Adaptive Functioning via Adaptive Behavior System -2nd Edition Behavior via Behavior Assessment for Children & Parent Stress Index
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
- Subject must be diagnosed with partial seizures and/or secondary generalization or
primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic
seizures)
- Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate
monotherapy.
- Mothers must not have a history of drug abuse (including alcohol) in the last year and
have no sequelae of drug abuse.
- Mothers must be able to maintain an accurate seizure diary of major motor seizures
- Subjects must have an IQ greater than or equal to 70 points.
- Subjects must have a history of a negative RPR and HIV.
- Subjects must not have progressive cerebral disease or presence of other major medical
illness
- Subjects must not have exposure to known teratogens during pregnancy, except AEDs.
- Subjects must not have poor compliance with prenatal care.
- Subjects must have adequate reading skills to perform the cognitive tests.
Locations and Contacts
University of Liverpool, Liverpool L9 7LJ, United Kingdom
University of Alabama, Birmingham, Alabama 32294, United States
Arizona Health Sciences, Tucson, Arizona 85724, United States
University of Southern California, Los Angeles, California 90033, United States
Georgetown University, Washington, District of Columbia 20007, United States
University of Florida, Gainesville, Florida 32611, United States
Emory University, Atlanta, Georgia 30322, United States
Medical College of Georgia, Augusta, Georgia 30912, United States
RUSH University Medical Center, Chicago, Illinois 60612, United States
Via Christi Medical Center, Wichita, Kansas 67214, United States
Brigham & Womens' Hospital, Boston, Massachusetts 02115, United States
Henry Ford Hospital, Detroit, Michigan 48202, United States
Minnesota Epilepsy Group, St. Paul, Minnesota 55102, United States
Columbia University, New York, New York 10032, United States
Wake Forest University Baptist Medical Center, Winston Salem, North Carolina 27157, United States
Case Western Reserve University, Cleveland, Ohio 44102, United States
University of Cincinnati, Cincinnati, Ohio 45219, United States
Ohio State University, Columbus, Ohio 43210, United States
Riddle Health Care II, Media, Pennsylvania 19063, United States
Baylor Medical Center, Irving, Texas 75061, United States
University of Utah, Salt Lake City, Utah 84132, United States
University of Washington, Seattle, Washington 98104, United States
Additional Information
Click here for more information about this study and a list of recruiting centers
Starting date: September 2000
Ending date: August 2010
Last updated: December 17, 2007
|
