Study of Antiepileptic Drug Effects on Child Development
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00353886|
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : July 23, 2007
|Condition or disease||Intervention/treatment|
|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|
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|
|Actual Enrollment :||81 participants|
|Observational Model:||Defined Population|
|Official Title:||Retrospective Study of In Utero Antiepileptic Drug Effects in Neurodevelopment|
|Study Start Date :||September 2002|
|Actual Study Completion Date :||June 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353886
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, District of Columbia|
|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, 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|
|University of Aberdeen|
|Aberdeen, United Kingdom, AB25 2ZR|
|Principal Investigator:||Gregory Lee, Ph.D.||Augusta University|
|Study Chair:||Kimford J. Meador, MD||University of Florida|