Study of Antiepileptic Drug Effects on Child Development

Completed

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT00353886

Run by

Augusta University

People needed

81

Starts

2002-09-01

Expected to finish

2007-06-01

Last updated by the study team

2007-07-23

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Boston University — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Epilepsy Group — Saint Paul, Minnesota, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Aberdeen — Aberdeen, United Kingdom

Full record on ClinicalTrials.gov

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