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| Name | Class |
|---|---|
| Epilepsy Foundation | OTHER |
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Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine | No intervention |
| |
| Valproate | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention. This is a cross-sectional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Folate Receptor Autoantibodies | ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women. | On the same day after informed consent was obtained |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in epilepsy and/or psychiatric clinics
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Harden, MD | North Shore-Long Island Jewish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore Long Island Jewish Health System | Great Neck | New York | 11021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lamotrigine | Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate. |
| FG001 | Valproate | Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lamotrigine | Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate. |
| BG001 | Valproate | Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Levels of Folate Receptor Autoantibodies | ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women. | Posted | Mean | Standard Deviation | ug/mL | On the same day after informed consent was obtained |
|
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This is a cross-sectional 1 visit study. No Adverse Event were collected or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lamotrigine | Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Connie Lau, MS, CCRC | North Shore-LIJ Health System | 516-325-7022 | clau@nshs.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
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| Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Valproate | Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine. | 0 | 0 | 0 | 0 |
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