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


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Seizure Disorder


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

This study is no longer recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

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?

Condition Treatment or Intervention
Epilepsy
Seizure
Cognition Disorders
 Drug: carbamazepine
 Drug: phenytoin
 Drug: valproate
 Drug: lamotrigine

MedlinePlus related topics:  Epilepsy;   Mental Health;   Seizures

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Neurodevelopmental Effects of Antiepileptic Drugs: the NEAD Study

Further Study Details: 

Expected Total Enrollment:  331

Study start: September 2000;  Study completion: August 2005

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.

Eligibility

Genders Eligible for Study:  Female

Criteria

  • 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.

Location Information


Florida
      University of Florida, Gainesville,  Florida,  United States

Study chairs or principal investigators

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

More Information

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

Study ID Numbers:  R01NS038455
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  August 8, 2001
ClinicalTrials.gov Identifier:  NCT00021866
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: October 1, 2005
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