Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 6:03 PM
Study NCT ID:
NCT00021866
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2001-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025953', 'term': 'amsonic acid'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Venous blood for AED levels Cord Blood for G6PD, Homocysteine Saliva for drug metabolizing enzymes, antioxidant enzymes, DNA repair enzymes, drug membrane transporter proteins and folate-related genes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2001-08-08', 'studyFirstSubmitQcDate': '2001-08-09', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child IQ as measured by the Differential Abilities Scale at 6 Years of age', 'timeFrame': '6 years'}], 'secondaryOutcomes': [{'measure': 'Executive Functioning,Tower-NEPSY', 'timeFrame': '6 Years'}, {'measure': 'Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales', 'timeFrame': '6 Years'}, {'measure': 'Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale', 'timeFrame': '6 Years'}, {'measure': "Memory via Children's Memory Scale", 'timeFrame': '6 Years'}, {'measure': 'Motor Functioning via Grooved Pegboard', 'timeFrame': '6 Years'}, {'measure': 'Academic Functioning via Wide Range Achievement Test', 'timeFrame': '6 Years'}, {'measure': 'Adaptive Functioning via Adaptive Behavior System -2nd Edition', 'timeFrame': '6 Years'}, {'measure': 'Behavior via Behavior Assessment for Children & Parent Stress Index', 'timeFrame': '6 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['epilepsy', 'seizure', 'pregnancy', 'antiepileptic', 'AED', 'carbamazepine', 'phenytoin', 'valproate', 'lamotrigine', 'child', 'behavior'], 'conditions': ['Epilepsy', 'Seizure', 'Cognition Disorders']}, 'referencesModule': {'references': [{'type': 'RESULT', '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.'}, {'type': 'RESULT', 'citation': 'Meador KJ, Page P, Liporace J, Kalayjian L, NEAD Study Group. Antiepileptic Drugs in Pregnancy. Neurology 2004;62 (Suppl 5):A311.'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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'}, {'pmid': '16894099', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31871217', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24934501', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '23352199', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://web.emmes.com/study/monead', 'label': 'Click here for more information about this study and a list of recruiting centers'}]}, 'descriptionModule': {'briefSummary': '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?', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': '* Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures)\n* Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy.\n* Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse.\n* Mothers must be able to maintain an accurate seizure diary of major motor seizures\n* Subjects must have an IQ greater than or equal to 70 points.\n* Subjects must have a history of a negative RPR and HIV.\n* Subjects must not have progressive cerebral disease or presence of other major medical illness\n* Subjects must not have exposure to known teratogens during pregnancy, except AEDs.\n* Subjects must not have poor compliance with prenatal care.\n* Subjects must have adequate reading skills to perform the cognitive tests.'}, 'identificationModule': {'nctId': 'NCT00021866', 'briefTitle': 'Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study', 'orgStudyIdInfo': {'id': '0334-2001'}, 'secondaryIdInfos': [{'id': '2R01NS038455', 'link': 'https://reporter.nih.gov/quickSearch/2R01NS038455', 'type': 'NIH'}, {'id': '2R01NS038455-06', 'link': 'https://reporter.nih.gov/quickSearch/2R01NS038455-06', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carbamazepine', 'description': 'Children and their mothers exposed to Carbamazepine monotherapy in utero', 'interventionNames': ['Behavioral: Differential Abilities Scale', 'Behavioral: Neuropsychological Testing']}, {'label': 'Phenytoin', 'description': 'Children and their mothers exposed to phenytoin in utero', 'interventionNames': ['Behavioral: Differential Abilities Scale', 'Behavioral: Neuropsychological Testing']}, {'label': 'Lamotrigine', 'description': 'Children and their mothers exposed to Lamotrigine in utero', 'interventionNames': ['Behavioral: Differential Abilities Scale', 'Behavioral: Neuropsychological Testing']}, {'label': 'Valproate', 'description': 'Children and their mothers exposed to Valproate in utero', 'interventionNames': ['Behavioral: Differential Abilities Scale', 'Behavioral: Neuropsychological Testing']}], 'interventions': [{'name': 'Differential Abilities Scale', 'type': 'BEHAVIORAL', 'otherNames': ['DAS'], 'description': 'IQ measurement at 3, 4.5 and 6 years of age', 'armGroupLabels': ['Carbamazepine', 'Lamotrigine', 'Phenytoin', 'Valproate']}, {'name': 'Neuropsychological Testing', 'type': 'BEHAVIORAL', 'otherNames': ['(Toni-3) Test of Nonverbal Intelligence', '(WAIS) - Wechslers Adult Intelligence Scale -revised', 'Beck Depression Inventory', 'Bayley Scales of Infant Development,', 'NEPSY', 'Trails Preschool', 'Preschool Language Scale-4', 'Expressive One-Word Vocabulary TEst', 'Peabody Picture Vocabulary Test', 'Developmental Test of Visual-Motor Integration', "Children's Memory Scale", 'Grooved Pegboard', 'Bracken Basic Concepts Scale', 'Wide Range Achievement TEst', 'Adaptive Behavior Assessment Scale', 'Behavioral Assessment for Children', 'Parenting Stress Index'], 'description': 'Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age', 'armGroupLabels': ['Carbamazepine', 'Lamotrigine', 'Phenytoin', 'Valproate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Health Sciences', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'RUSH University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Womens' Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Epilepsy Group', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44102', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Riddle Health Care II', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '75061', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Medical Center', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'L9 7LJ', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'University of Liverpool', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Kimford J. Meador, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University, Atlanta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kimford J. Meador, MD', 'investigatorAffiliation': 'Emory University'}}}}