Status:
COMPLETED
Study of Antiepileptic Drug Effects on Child Development
Lead Sponsor:
Augusta University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
6-16 years
Brief Summary
The specific aim of this study is to determine if in utero exposure produces differential antiepileptic drug (AED) effects on subsequent cognitive abilities and behavioral abnormalities in children
Detailed Description
Subject groups will include 120 children (6 - 16 year/old) of women with epilepsy, who were exposed to one of the following anti-epileptic drugs during the mother's pregnancy with that child: Carbamaz...
Eligibility Criteria
Inclusion
- Children presently 6-16 years/old who were exposed in utero to monotherapy with carbamazepine, phenytoin, or valproate because their mother had epilepsy and was taking one of these monotherapies while pregnant with the child.
- In utero exposure should be at least 6 months.
- Children of the same mother may be enrolled if each child was exposed to a different AED monotherapy (e.g. carbamazepine, phenytoin, or valproate) during their mother's pregnancy.
- Mother's primary language should be English or Spanish.
- The mother was 18-35 years of age when the child was born (inclusive).
Exclusion
- Child was exposed to another known teratogen during their mother's pregnancy other than the target AEDs in monotherapy.
- Child is presently on a centrally active medication other than sympathomimetics (e.g. Ritalin) for ADD or ADHD. Child should be off the sympathomimetic for at least 24 hours prior to testing.
- Child has or has had a serious brain injury (e.g., severe head trauma) or serious medical illness (e.g., cancer) unrelated to AED exposure, which may affect the child's cognitive abilities.
- Mother has IQ \< 70.
- Mother has a progressive brain lesion (e.g., tumor).
- Mother had serious medical illness or complication during this child's pregnancy, which was unrelated to AED or epilepsy.
- Mother has known history of drug or alcohol abuse within the previous 12 months or has sequelae of drug abuse.
- There is a known history of child abuse.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00353886
Start Date
September 1 2002
End Date
June 1 2007
Last Update
July 23 2007
Active Locations (10)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Georgetown University
Washington D.C., District of Columbia, United States, 20057
3
University of Florida
Gainesville, Florida, United States, 32610
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322