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Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

NCT ID: NCT01231646

Last Updated: 2015-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Psychiatric or Mood Diseases or Conditions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lamotrigine

No intervention

No intervention

Intervention Type OTHER

No intervention. This is a cross-sectional study.

Valproate

No intervention

No intervention

Intervention Type OTHER

No intervention. This is a cross-sectional study.

Interventions

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No intervention

No intervention. This is a cross-sectional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
* Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.

Exclusion Criteria

* Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Epilepsy Foundation

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia Harden, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore-Long Island Jewish Medical Center

Locations

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North Shore Long Island Jewish Health System

Great Neck, New York, United States

Site Status

Countries

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United States

Other Identifiers

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10-266A

Identifier Type: -

Identifier Source: org_study_id