Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT01097720
Status:
UNKNOWN
Last Update Posted:
2010-04-02
First Post:
2010-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-31', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-03-31', 'lastUpdatePostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adaptive Behavior Scores', 'timeFrame': '36-83 months of age', 'description': "Measures of each child's Adaptive Behavior scores as assessed by the Vineland-II Adaptive Behavior Scales, collected when the child was between 36 and 83 months of age."}], 'secondaryOutcomes': [{'measure': 'Presence/Absence of Major Malformations', 'timeFrame': '36-83 months of age', 'description': 'Based on interview with mother and review of medical records, determination is made as to whether or not the child had any major malformations at birth.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Valproate', 'Lamotrigine', 'Carbamazepine', 'Anticonvulsant', 'Antiepileptic', 'Teratogen', 'Autism', 'Developmental Delay'], 'conditions': ['Autism', 'Developmental Delay', 'Birth Defects']}, 'descriptionModule': {'briefSummary': 'This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include:\n\n1. Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.\n2. Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.\n3. The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations.\n4. The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester.\n\nThe study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '83 Months', 'minimumAge': '36 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 36-83 months of age, prenatally exposed to LTG, VPA, or CBZ monotherapies, recruited through mothers enrolled in the North American Antiepileptic Drug Pregnancy Registry.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 36-83 months of age\n* Prenatal exposure to LTG, VPA, or CBZ monotherapy\n* AED was used by mother to suppress seizures\n* Mother was enrolled in the North American AED Pregnancy Registry\n\nExclusion Criteria:\n\n* Exposure during the first trimester to other known teratogens.\n* Mother with mental health issues\n* Refusal to release medical records to confirm eligibility.'}, 'identificationModule': {'nctId': 'NCT01097720', 'briefTitle': 'Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine', 'orgStudyIdInfo': {'id': '2005P000379'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LTG-exposed', 'description': 'Children exposed to LTG during pregnancy.'}, {'label': 'VPA-exposed', 'description': 'Children exposed to VPA during pregnancy.'}, {'label': 'CBZ-exposed', 'description': 'Children exposed to CBZ during pregnancy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lewis B. Holmes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Jane Adams, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Massachusetts, Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Lewis B. Holmes, MD', 'oldOrganization': 'Massachusetts General Hospital'}}}}