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EpilepsyNCT00021866

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

An observational study of Epilepsy and Seizure, run by Emory University at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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? Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Epilepsy, Seizure, Cognition Disorders
What is being tested?
Differential Abilities Scale and Neuropsychological Testing
How many people
331 participants
Where
21 sitesin 2 countries
Study dates
Sep 2000to Aug 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Mothers and their child(ren) who were exposed to one of the following monotherapies in utero- Lamotrigine, Carbamazepine, Phenytoin, or Valproate. Fathers of the children and a first degree materal relative of the mother are also invited to have IQ testing and medical history

  • 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.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States20 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Alabama

    Birmingham, Alabama, 32294

  • Brigham & Womens' Hospital

    Boston, Massachusetts, 02115

  • RUSH University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44102

  • Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Baylor Medical Center

    Irving, Texas, 75061

  • University of Southern California

    Los Angeles, California, 90033

  • Riddle Health Care II

    Media, Pennsylvania, 19063

  • Columbia University

    New York, New York, 10032

  • Minnesota Epilepsy Group

    Saint Paul, Minnesota, 55102

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Washington

    Seattle, Washington, 98104

  • Arizona Health Sciences

    Tucson, Arizona, 85724

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Via Christi Medical Center

    Wichita, Kansas, 67214

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom1 site

  • University of Liverpool

    Liverpool, L9 7LJ

Other trials in United Kingdom

About this study

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?

Read the 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.

Being tested
Differential Abilities Scale, Neuropsychological Testing
Keywords
epilepsy, seizure, pregnancy, antiepileptic, AED, carbamazepine, phenytoin, valproate, lamotrigine, child, behavior
Medical subject headings
Epilepsy, Seizures, Cognition Disorders, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Differential Abilities ScaleBehavioural

    Also called DAS

    IQ measurement at 3, 4.5 and 6 years of age

  • Neuropsychological TestingBehavioural

    Also called (Toni-3) Test of Nonverbal Intelligence, (WAIS) - Wechslers Adult Intelligence Scale -revised, Beck Depression Inventory, Bayley Scales of Infant Development,

    Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age

Study groups in NCT00021866
Study groupRoleWhat they receive
CarbamazepineChildren and their mothers exposed to Carbamazepine monotherapy in utero
Receives: Behavioral: Differential Abilities Scale; Behavioral: Neuropsychological Testing
PhenytoinChildren and their mothers exposed to phenytoin in utero
Receives: Behavioral: Differential Abilities Scale; Behavioral: Neuropsychological Testing
LamotrigineChildren and their mothers exposed to Lamotrigine in utero
Receives: Behavioral: Differential Abilities Scale; Behavioral: Neuropsychological Testing
ValproateChildren and their mothers exposed to Valproate in utero
Receives: Behavioral: Differential Abilities Scale; Behavioral: Neuropsychological Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child IQ as measured by the Differential Abilities Scale at 6 Years of age

    Measured: 6 years

Secondary outcomes (8)

  1. Executive Functioning,Tower-NEPSY

    Measured: 6 Years

  2. Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales

    Measured: 6 Years

  3. Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale

    Measured: 6 Years

  4. Memory via Children's Memory Scale

    Measured: 6 Years

  5. Motor Functioning via Grooved Pegboard

    Measured: 6 Years

  6. Academic Functioning via Wide Range Achievement Test

    Measured: 6 Years

  7. Adaptive Functioning via Adaptive Behavior System -2nd Edition

    Measured: 6 Years

  8. Behavior via Behavior Assessment for Children & Parent Stress Index

    Measured: 6 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2001 (estimated)
  2. Study startSep 2000
  3. Primary completionAug 2010
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Family based
Time perspective
Prospective
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00021866
Sponsor's protocol ID
0334-2001
Other IDs
2R01NS038455, 2R01NS038455-06
Status last verified
Sep 2013
First submitted
8 Aug 2001
Last updated
11 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16894099

  • Meador KJ, Pennell PB, May RC, Brown CA, Baker G, Bromley R, Loring DW, Cohen MJ; NEAD Investigator Group. Effects of periconceptional folate on cognition in children of women with epilepsy: NEAD study. Neurology. 2020 Feb 18;94(7):e729-e740. doi: 10.1212/WNL.0000000000008757. Epub 2019 Dec 23.

    PubMed 31871217

  • Meador KJ, Baker GA, Browning N, Cohen MJ, Bromley RL, Clayton-Smith J, Kalayjian LA, Kanner A, Liporace JD, Pennell PB, Privitera M, Loring DW; Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study Group. Breastfeeding in children of women taking antiepileptic drugs: cognitive outcomes at age 6 years. JAMA Pediatr. 2014 Aug;168(8):729-36. doi: 10.1001/jamapediatrics.2014.118.

    PubMed 24934501

  • Meador KJ, Baker GA, Browning N, Cohen MJ, Bromley RL, Clayton-Smith J, Kalayjian LA, Kanner A, Liporace JD, Pennell PB, Privitera M, Loring DW; NEAD Study Group. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurol. 2013 Mar;12(3):244-52. doi: 10.1016/S1474-4422(12)70323-X. Epub 2013 Jan 23.

    PubMed 23352199

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Seizure, run by Emory University at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child IQ as measured by the Differential Abilities Scale at 6 Years of age (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00021866, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.

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