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

Epilepsy Clinical Trial

Official title:

Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021866
• Other study ID #: 0334-2001
• Secondary ID: 2RO1NS384552R01N
• Status: Completed
• Phase: N/A
• First received: August 8, 2001
• Last updated: November 8, 2013
• Start date: September 2000
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: August 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

• 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.

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Epilepsy
• Seizure

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Liverpool	Liverpool
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	Brigham & Womens' Hospital	Boston	Massachusetts
United States	RUSH University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Baylor Medical Center	Irving	Texas
United States	University of Southern California	Los Angeles	California
United States	Riddle Health Care II	Media	Pennsylvania
United States	Columbia University	New York	New York
United States	University of Utah	Salt Lake City	Utah
United States	University of Washington	Seattle	Washington
United States	Minnesota Epilepsy Group	St. Paul	Minnesota
United States	Arizona Health Sciences	Tucson	Arizona
United States	Georgetown University	Washington	District of Columbia
United States	Via Christi Medical Center	Wichita	Kansas
United States	Wake Forest University Baptist Medical Center	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (5)

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 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. — View Citation

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 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child IQ as measured by the Differential Abilities Scale at 6 Years of age		6 years	No
Secondary	Executive Functioning,Tower-NEPSY		6 Years	No
Secondary	Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales		6 Years	No
Secondary	Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale		6 Years	No
Secondary	Memory via Children's Memory Scale		6 Years	No
Secondary	Motor Functioning via Grooved Pegboard		6 Years	No
Secondary	Academic Functioning via Wide Range Achievement Test		6 Years	No
Secondary	Adaptive Functioning via Adaptive Behavior System -2nd Edition		6 Years	No
Secondary	Behavior via Behavior Assessment for Children & Parent Stress Index		6 Years	No

External Links

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