Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Epilepsy Clinical Trial

Official title:

Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231646
• Other study ID #: 10-266A
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: October 23, 2015
• Start date: October 2010
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Epilepsy
• Psychiatric or Mood Diseases or Conditions

Intervention

Other:
• No intervention
No intervention. This is a cross-sectional study.

Locations

Country	Name	City	State
United States	North Shore Long Island Jewish Health System	Great Neck	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Epilepsy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	On the same day after informed consent was obtained	No