TONI-3 and WRAT-3 and Connor's Rating Scales PRS & TRS in Epilepsy - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Epilepsy

Intervention / Treatment

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: 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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZR
    - University of Aberdeen
United States
- California
  - Los Angeles, California, United States, 90033
    - University of Southern California
- District of Columbia
  - Washington, District of Columbia, United States, 20057
    - Georgetown University
- Florida
  - Gainesville, Florida, United States, 32610
    - University of Florida
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University School of Medicine
  - Augusta, Georgia, United States, 30912
    - Medical College of Georgia
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston University
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
- Minnesota
  - St. Paul, Minnesota, United States, 55102
    - Minnesota Epilepsy Group
- Ohio
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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 Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

GlaxoSmithKline

Investigators

Principal Investigator: Gregory Lee, Ph.D., Augusta University
Study Chair: Kimford J. Meador, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria