Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
NCT ID: NCT00021866
Last Updated: 2013-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
331 participants
OBSERVATIONAL
2000-09-30
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
FAMILY_BASED
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Carbamazepine
Children and their mothers exposed to Carbamazepine monotherapy in utero
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
Phenytoin
Children and their mothers exposed to phenytoin in utero
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
Lamotrigine
Children and their mothers exposed to Lamotrigine in utero
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
Valproate
Children and their mothers exposed to Valproate in utero
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kimford J. Meador, MD
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kimford J. Meador, M.D.
Role: PRINCIPAL_INVESTIGATOR
Emory University, Atlanta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama
Birmingham, Alabama, United States
Arizona Health Sciences
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
RUSH University Medical Center
Chicago, Illinois, United States
Via Christi Medical Center
Wichita, Kansas, United States
Brigham & Womens' Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, United States
Columbia University
New York, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Riddle Health Care II
Media, Pennsylvania, United States
Baylor Medical Center
Irving, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
University of Liverpool
Liverpool, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information about this study and a list of recruiting centers
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.