Study of Antiepileptic Drug Effects on Child Development

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00353886
First received: July 17, 2006
Last updated: July 19, 2007
Last verified: July 2007
  Purpose

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


Condition Intervention
Epilepsy
Procedure: TONI-3
Procedure: WRAT-3
Procedure: Connor's Rating Scales PRS & TRS
Procedure: Peabody Picture Vocabulary Test
Procedure: Children's Memory Scale
Procedure: WISC-3
Procedure: Behavioral Assessment System for Children PRS & TRS

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Retrospective Study of In Utero Antiepileptic Drug Effects in Neurodevelopment

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Enrollment: 81
Study Start Date: September 2002
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353886

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Epilepsy Group
St. Paul, Minnesota, United States, 55102
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United Kingdom
University of Aberdeen
Aberdeen, United Kingdom, AB25 2ZR
Sponsors and Collaborators
Georgia Regents University
GlaxoSmithKline
Investigators
Principal Investigator: Gregory Lee, Ph.D. Georgia Regents University
Study Chair: Kimford J. Meador, MD University of Florida
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00353886     History of Changes
Other Study ID Numbers: RNEAD
Study First Received: July 17, 2006
Last Updated: July 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgia Regents University:
Retrospective
Epilepsy
Antiepileptic Drugs
Behavioral Development
Intellectual Development

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014