EpilepsyNCT00353886
Study of Antiepileptic Drug Effects on Child Development
An observational study of Epilepsy, run by Augusta University at 10 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- TONI-3, WRAT-3 and Connor's Rating Scales PRS & TRS
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2002to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
Boston University
Boston, Massachusetts, 02118
Case Western Reserve University
Cleveland, Ohio, 44106
Henry Ford Hospital
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32610
University of Southern California
Los Angeles, California, 90033
Minnesota Epilepsy Group
Saint Paul, Minnesota, 55102
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Retrospective Study of In Utero Antiepileptic Drug Effects in Neurodevelopment
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
Read the 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.
- Conditions
- Epilepsy
- Being tested
- TONI-3, WRAT-3, Connor's Rating Scales PRS & TRS, Peabody Picture Vocabulary Test, Children's Memory Scale
- Keywords
- Retrospective, Epilepsy, Antiepileptic Drugs, Behavioral Development, Intellectual Development
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TONI-3Procedure or surgery
WRAT-3Procedure or surgery
Connor's Rating Scales PRS & TRSProcedure or surgery
Peabody Picture Vocabulary TestProcedure or surgery
Children's Memory ScaleProcedure or surgery
WISC-3Procedure or surgery
Behavioral Assessment System for Children PRS & TRSProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startSep 2002
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Gregory Lee, Ph.D., Principal investigator, Augusta UniversityKimford J. Meador, MD, Study chair, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353886
- Sponsor's protocol ID
- RNEAD
- Status last verified
- Jul 2007
- First submitted
- 17 Jul 2006
- Last updated
- 23 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of In Utero Antiepileptic Drug Effects in Neurodevelopment
- ClinicalTrials.gov ID
- NCT00353886
- Acronym / sponsor ID
- RNEAD
- Conditions
- Epilepsy
- Keywords
- Retrospective, Epilepsy, Antiepileptic Drugs, Behavioral Development, Intellectual Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2002
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TONI-3 | Procedure or surgery | – |
| WRAT-3 | Procedure or surgery | – |
| Connor's Rating Scales PRS & TRS | Procedure or surgery | – |
| Peabody Picture Vocabulary Test | Procedure or surgery | – |
| Children's Memory Scale | Procedure or surgery | – |
| WISC-3 | Procedure or surgery | – |
| Behavioral Assessment System for Children PRS & TRS | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2007.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Lee, Ph.D. principal investigator
Augusta University
Kimford J. Meador, MD study chair
University of Florida
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Augusta University at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2007.