Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimford J. Meador, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00021866
First received: August 8, 2001
Last updated: November 8, 2013
Last verified: September 2013

August 8, 2001
November 8, 2013
September 2000
August 2010   (final data collection date for primary outcome measure)
Child IQ as measured by the Differential Abilities Scale at 6 Years of age [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00021866 on ClinicalTrials.gov Archive Site
  • Executive Functioning,Tower-NEPSY [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Memory via Children's Memory Scale [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Motor Functioning via Grooved Pegboard [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Academic Functioning via Wide Range Achievement Test [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Adaptive Functioning via Adaptive Behavior System -2nd Edition [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Behavior via Behavior Assessment for Children & Parent Stress Index [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study

The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?

This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.

Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Venous blood for AED levels Cord Blood for G6PD, Homocysteine Saliva for drug metabolizing enzymes, antioxidant enzymes, DNA repair enzymes, drug membrane transporter proteins and folate-related genes

Non-Probability Sample

Mothers and their child(ren) who were exposed to one of the following monotherapies in utero- Lamotrigine, Carbamazepine, Phenytoin, or Valproate. Fathers of the children and a first degree materal relative of the mother are also invited to have IQ testing and medical history

  • Epilepsy
  • Seizure
  • Cognition Disorders
  • Behavioral: Differential Abilities Scale
    IQ measurement at 3, 4.5 and 6 years of age
    Other Name: DAS
  • Behavioral: Neuropsychological Testing
    Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
    Other Names:
    • (Toni-3) Test of Nonverbal Intelligence
    • (WAIS) - Wechslers Adult Intelligence Scale -revised
    • Beck Depression Inventory
    • Bayley Scales of Infant Development,
    • NEPSY
    • Trails Preschool
    • Preschool Language Scale-4
    • Expressive One-Word Vocabulary TEst
    • Peabody Picture Vocabulary Test
    • Developmental Test of Visual-Motor Integration
    • Children's Memory Scale
    • Grooved Pegboard
    • Bracken Basic Concepts Scale
    • Wide Range Achievement TEst
    • Adaptive Behavior Assessment Scale
    • Behavioral Assessment for Children
    • Parenting Stress Index
  • Carbamazepine
    Children and their mothers exposed to Carbamazepine monotherapy in utero
    Interventions:
    • Behavioral: Differential Abilities Scale
    • Behavioral: Neuropsychological Testing
  • Phenytoin
    Children and their mothers exposed to phenytoin in utero
    Interventions:
    • Behavioral: Differential Abilities Scale
    • Behavioral: Neuropsychological Testing
  • Lamotrigine
    Children and their mothers exposed to Lamotrigine in utero
    Interventions:
    • Behavioral: Differential Abilities Scale
    • Behavioral: Neuropsychological Testing
  • Valproate
    Children and their mothers exposed to Valproate in utero
    Interventions:
    • Behavioral: Differential Abilities Scale
    • Behavioral: Neuropsychological Testing

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
August 2012
August 2010   (final data collection date for primary outcome measure)
  • Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures)
  • Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy.
  • Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse.
  • Mothers must be able to maintain an accurate seizure diary of major motor seizures
  • Subjects must have an IQ greater than or equal to 70 points.
  • Subjects must have a history of a negative RPR and HIV.
  • Subjects must not have progressive cerebral disease or presence of other major medical illness
  • Subjects must not have exposure to known teratogens during pregnancy, except AEDs.
  • Subjects must not have poor compliance with prenatal care.
  • Subjects must have adequate reading skills to perform the cognitive tests.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00021866
0334-2001, 2RO1NS38455, 2R01NS038455-06
Yes
Kimford J. Meador, MD, Emory University
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Kimford J. Meador, M.D. Emory University, Atlanta
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP