Study of Antiepileptic Drug Effects on Child Development

Epilepsy Clinical Trial

Official title:

Retrospective Study of In Utero Antiepileptic Drug Effects in Neurodevelopment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353886
• Other study ID #: RNEAD
• Status: Completed
• Phase: N/A
• First received: July 17, 2006
• Last updated: July 19, 2007
• Start date: September 2002
• Est. completion date: June 2007

Study information

• Verified date: July 2007
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

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: Carbamazepine/Tegretol, Valproate/Depakote, and Phenytoin/Dilantin.

In addition to the children, their mother, father and a primary relative of the mother will also be asked participate in the study. Children cannot be enrolled if they were exposed to another known teratogen during their mother’s pregnancy other than the target AEDs in monotherapy; if the child has or has had a serious brain injury (e.g. severe head trauma) or serious medical illness (e.g. cancer), which is unrelated to AED exposure and may affect the child’s cognitive abilities. Other exclusion criteria include, maternal IQ <70; mother has a progressive brain lesion (e.g. tumor) or mother had serious medical illness or complication during this child’s pregnancy, which was unrelated to AED or epilepsy, history or maternal alcohol or drug abuse in past 12 months, and history of child abuse. If possible, the child should be off sympathomimetic medications (e.g. Ritalin) for 24 hours prior to testing if he/she is being treated for ADD or ADHD.

Procedures: The primary test is the IQ (TONI-3) in the children. Additional tests in the children include the Peabody Picture Vocabulary Test –3; WRAT spelling, math & reading subtests; Children’s Memory Scale: story memory subtest (immediate, delayed, & delayed recognition subscales); WISC-III coding subtest; Behavioral Assessment System for Children (parent and teacher scales) and the Conner’s Rating Scale – (parent and teacher rating scales).

Collected information about the mother includes social and medical factors of the mother, specifically age, type of epilepsy, AED & estimated months exposed and average dose during pregnancy, estimated seizure frequency during pregnancy (by types including status), any other major medical illnesses during pregnancy, primary language, education level and socioeconomic status. The mother will also have an IQ (TONI-3) test.

Collected information about the child include: age, gender, gestational age at birth (i.e. full or pre-term), birth order & # sibs, primary language at home, Birth defects, Hx ADD or ADHD; other major medical illnesses (include perinatal complications); special education requirements of the child; and remedial math or reading requirements of child.

Collected information about the father and primary relative include: age, relationship to mother (for primary relative), primary language, education level, socioeconomic status, any major medical illnesses (especially those which could affect IQ). The relative and father will also have an IQ (TONI-3) test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

1. 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.

2. In utero exposure should be at least 6 months.

3. 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.

4. Mother’s primary language should be English or Spanish.

5. The mother was 18-35 years of age when the child was born (inclusive).

Exclusion Criteria:

1. Child was exposed to another known teratogen during their mother’s pregnancy other than the target AEDs in monotherapy.

2. 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.

3. 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.

4. Mother has IQ < 70.

5. Mother has a progressive brain lesion (e.g., tumor).

6. Mother had serious medical illness or complication during this child’s pregnancy, which was unrelated to AED or epilepsy.

7. Mother has known history of drug or alcohol abuse within the previous 12 months or has sequelae of drug abuse.

8. There is a known history of child abuse.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Epilepsy

Intervention

Procedure:
• TONI-3

• WRAT-3

• Connor's Rating Scales PRS & TRS

• Peabody Picture Vocabulary Test

• Children's Memory Scale

• WISC-3

• Behavioral Assessment System for Children PRS & TRS

Locations

Country	Name	City	State
United Kingdom	University of Aberdeen	Aberdeen
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	Case Western Reserve University	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida	Gainesville	Florida
United States	University of Southern California	Los Angeles	California
United States	Minnesota Epilepsy Group	St. Paul	Minnesota
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Regents University	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  United Kingdom, 

External Links

•   Link