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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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:
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTG-exposed | Children exposed to LTG during pregnancy. | ||
| VPA-exposed | Children exposed to VPA during pregnancy. | ||
| CBZ-exposed | Children exposed to CBZ during pregnancy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adaptive Behavior Scores | 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. | 36-83 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/Absence of Major Malformations | 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. | 36-83 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lewis B. Holmes, MD | Massachusetts General Hospital | Principal Investigator |
| Jane Adams, Ph.D. | University of Massachusetts, Boston | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D007859 | Learning Disabilities |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |