Official Title: “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?

Study Type: Observational

Study Design: Family-Based, Prospective

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.

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

• : 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

Primary Measures

• Child IQ as measured by the Differential Abilities Scale at 6 Years of age
  • Time Frame: 6 years
    Safety Issue?: No

Secondary Measures

• Executive Functioning,Tower-NEPSY
  • Time Frame: 6 Years
    Safety Issue?: No
• Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales
  • Time Frame: 6 Years
    Safety Issue?: No
• Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale
  • Time Frame: 6 Years
    Safety Issue?: No
• Memory via Children's Memory Scale
  • Time Frame: 6 Years
    Safety Issue?: No
• Motor Functioning via Grooved Pegboard
  • Time Frame: 6 Years
    Safety Issue?: No
• Academic Functioning via Wide Range Achievement Test
  • Time Frame: 6 Years
    Safety Issue?: No
• Adaptive Functioning via Adaptive Behavior System -2nd Edition
  • Time Frame: 6 Years
    Safety Issue?: No
• Behavior via Behavior Assessment for Children & Parent Stress Index
  • Time Frame: 6 Years
    Safety Issue?: No

• 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 for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Florida

Overall Clinical Trial Officials and Contacts

Kimford J. Meador, M.D. Principal Investigator University of Florida  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00021866

Study ID Number: R01NS038455

ClinicalTrials.gov Identifier: NCT00021866

Health Authority: United States: Federal Government

Click here for more information about this study and a list of recruiting centers