Trial Outcomes & Findings for Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women? (NCT NCT01231646)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

38 participants

Primary outcome timeframe

On the same day after informed consent was obtained

Results posted on

2015-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Lamotrigine Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.	Valproate Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
Overall Study STARTED	28	10
Overall Study COMPLETED	28	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lamotrigine n=28 Participants Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.	Valproate n=10 Participants Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.	Total n=38 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 10.22 • n=5 Participants	39.1 years STANDARD_DEVIATION 7.77 • n=7 Participants	34.7 years STANDARD_DEVIATION 9.89 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	10 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	24.95 kg/m^2 STANDARD_DEVIATION 4.3 • n=5 Participants	30.47 kg/m^2 STANDARD_DEVIATION 7.2 • n=7 Participants	26.44 kg/m^2 STANDARD_DEVIATION 5.77 • n=5 Participants

PRIMARY outcome

Timeframe: On the same day after informed consent was obtained

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.

Outcome measures

Outcome measures
Measure	Lamotrigine n=27 Participants Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.	Valproate n=10 Participants Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
Levels of Folate Receptor Autoantibodies Immunoglobulin G	35.33 ug/mL Standard Deviation 27.14	35.21 ug/mL Standard Deviation 20.57
Levels of Folate Receptor Autoantibodies Immunoglobulin M	44.3 ug/mL Standard Deviation 34.18	41.81 ug/mL Standard Deviation 33.13
Levels of Folate Receptor Autoantibodies Immunoglobulin G and Immunoglobulin M	79.62 ug/mL Standard Deviation 50.12	77.06 ug/mL Standard Deviation 46.00

Adverse Events

Lamotrigine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Valproate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Connie Lau, MS, CCRC

North Shore-LIJ Health System

Phone: 516-325-7022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place