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

Overview

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?

Full Title of Study: “Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2010

Detailed Description

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.

Interventions

  • Behavioral: Differential Abilities Scale
    • IQ measurement at 3, 4.5 and 6 years of age
  • Behavioral: Neuropsychological Testing
    • Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age

Arms, Groups and Cohorts

  • Carbamazepine
    • Children and their mothers exposed to Carbamazepine monotherapy in utero
  • Phenytoin
    • Children and their mothers exposed to phenytoin in utero
  • Lamotrigine
    • Children and their mothers exposed to Lamotrigine in utero
  • Valproate
    • Children and their mothers exposed to Valproate in utero

Clinical Trial Outcome Measures

Primary Measures

  • Child IQ as measured by the Differential Abilities Scale at 6 Years of age
    • Time Frame: 6 years

Secondary Measures

  • Executive Functioning,Tower-NEPSY
    • Time Frame: 6 Years
  • Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales
    • Time Frame: 6 Years
  • Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale
    • Time Frame: 6 Years
  • Memory via Children’s Memory Scale
    • Time Frame: 6 Years
  • Motor Functioning via Grooved Pegboard
    • Time Frame: 6 Years
  • Academic Functioning via Wide Range Achievement Test
    • Time Frame: 6 Years
  • Adaptive Functioning via Adaptive Behavior System -2nd Edition
    • Time Frame: 6 Years
  • Behavior via Behavior Assessment for Children & Parent Stress Index
    • Time Frame: 6 Years

Participating in This Clinical Trial

  • 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.
  • Gender Eligibility: Female

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Emory University
    • Collaborator
      • National Institute of Neurological Disorders and Stroke (NINDS)
    • Provider of Information About this Clinical Study
      • Principal Investigator: Kimford J. Meador, MD, Professor – Emory University
    • Overall Official(s)
      • Kimford J. Meador, M.D., Principal Investigator, Emory University, Atlanta

    Citations Reporting on Results

    Meador KJ, Chadwick D, Clayton-Smith J, Pennell P, Liporace J, Kalayian L, and NEAD Study Group. Antiepileptic drugs in pregnancy: Differences in U.K. and U.S.A. Epilepsia, 2003;44 (Suppl. 9):289.

    Meador KJ, Page P, Liporace J, Kalayjian L, NEAD Study Group. Antiepileptic Drugs in Pregnancy. Neurology 2004;62 (Suppl 5):A311.

    Meador KJ, Baker GA, Clayton Smith J, Pennell P, Liporace J, Kalayjian L, Kini U, NEAD Study Group. Differential Effects of Antiepileptic Drugs on Serious Adverse Outcomes in Children Exposed In Utero. Epilepsia 2004;45 (Suppl 3):58

    Meador KM, Loring DW, Baker G, Smith JC, Pennell P, Liporace J, Kalayjian L, Kini U, NEAD Study Group. Differential and dose dependent effects of in utero antiepileptic drugs. Neurology 2005;64 (Suppl 1):A427

    Meador KJ, Baker GA, Finnell RH, Kalayjian LA, Liporace JD, Loring DW, Mawer G, Pennell PB, Smith JC, Wolff MC; NEAD Study Group. In utero antiepileptic drug exposure: fetal death and malformations. Neurology. 2006 Aug 8;67(3):407-12. doi: 10.1212/01.wnl.0000227919.81208.b2.

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