- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00021866
Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
November 8, 2013 updated by: Kimford J. Meador, MD, Emory University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
331
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Liverpool, United Kingdom, L9 7LJ
- University of Liverpool
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Alabama
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Birmingham, Alabama, United States, 32294
- University of Alabama
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Health Sciences
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Augusta, Georgia, United States, 30912
- Medical College of Georgia
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Kansas
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Wichita, Kansas, United States, 67214
- Via Christi Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Womens' Hospital
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Minnesota
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St. Paul, Minnesota, United States, 55102
- Minnesota Epilepsy Group
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New York
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New York, New York, United States, 10032
- Columbia University
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North Carolina
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Winston Salem, North Carolina, United States, 27157
- Wake Forest University Baptist Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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Cleveland, Ohio, United States, 44102
- Case Western Reserve University
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Columbus, Ohio, United States, 43210
- Ohio State University
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Pennsylvania
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Media, Pennsylvania, United States, 19063
- Riddle Health Care II
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Texas
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Irving, Texas, United States, 75061
- Baylor Medical Center
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Washington
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Seattle, Washington, United States, 98104
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Carbamazepine
Children and their mothers exposed to Carbamazepine monotherapy in utero
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IQ measurement at 3, 4.5 and 6 years of age
Other Names:
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
Phenytoin
Children and their mothers exposed to phenytoin in utero
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IQ measurement at 3, 4.5 and 6 years of age
Other Names:
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
Lamotrigine
Children and their mothers exposed to Lamotrigine in utero
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IQ measurement at 3, 4.5 and 6 years of age
Other Names:
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
Valproate
Children and their mothers exposed to Valproate in utero
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IQ measurement at 3, 4.5 and 6 years of age
Other Names:
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Child IQ as measured by the Differential Abilities Scale at 6 Years of age
Time Frame: 6 years
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6 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Executive Functioning,Tower-NEPSY
Time Frame: 6 Years
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6 Years
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Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales
Time Frame: 6 Years
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6 Years
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Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale
Time Frame: 6 Years
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6 Years
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Memory via Children's Memory Scale
Time Frame: 6 Years
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6 Years
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Motor Functioning via Grooved Pegboard
Time Frame: 6 Years
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6 Years
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Academic Functioning via Wide Range Achievement Test
Time Frame: 6 Years
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6 Years
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Adaptive Functioning via Adaptive Behavior System -2nd Edition
Time Frame: 6 Years
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6 Years
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Behavior via Behavior Assessment for Children & Parent Stress Index
Time Frame: 6 Years
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6 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kimford J. Meador, M.D., Emory University, Atlanta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2000
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 8, 2001
First Submitted That Met QC Criteria
August 9, 2001
First Posted (Estimate)
August 10, 2001
Study Record Updates
Last Update Posted (Estimate)
November 11, 2013
Last Update Submitted That Met QC Criteria
November 8, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0334-2001
- 2R01NS038455 (U.S. NIH Grant/Contract)
- 2R01NS038455-06 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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