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Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
This study is ongoing, but not recruiting participants.
Study NCT00021866   Information provided by Emory University
First Received: August 8, 2001   Last Updated: June 2, 2009   History of Changes

August 8, 2001
June 2, 2009
September 2000
 
Child IQ as measured by the Differential Abilities Scale at 6 Years of age [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Same as current
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 ]
Same as current
 
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
Family-Based, Prospective
  • Epilepsy
  • Seizure
  • Cognition Disorders
  • Behavioral: Differential Abilities Scale
  • Behavioral: Neuropsychological Testing
  • Children and their mothers exposed to Carbamazepine monotherapy in utero
  • Children and their mothers exposed to phenytoin in utero
  • Children and their mothers exposed to Lamotrigine in utero
  • Children and their mothers exposed to Valproate in utero
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
331
August 2010
 
  • 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
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00021866
Kimford J. Meador, M.D., Emory University
R01NS038455, 2RO1NS38455
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Kimford J. Meador, M.D. Emory University, Atlanta
Emory University
June 2009

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