Birth Defects Associated With Exposure to Lamotrigine in Pregnancy (EUROCAT)

CompletedOBSERVATIONAL
Enrollment

1

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Epilepsy
Interventions
DRUG

Lamotrigine monotherapy

Exposure to lamotrigine monotherapy in the first trimester of pregnancy (time period from first day of menstrual period to 12th week of gestation).

DRUG

No anti-epileptic drug exposure

No exposure to anti-epileptic drugs in the first trimester of pregnancy (time period from first day of menstrual period to 12th week of gestation).

DRUG

Non lamotrigine anti-epileptic drug monotherapy

Exposure to non lamotrigine monotherapy (with or without valproate) during the first trimester of pregnancy (time period from the first day of the menstrual period to the 12th week of gestation)

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY