AntiEpileptic drug Monitoring in PREgnancy: an evaluation of effectiveness, costeffectivenessand acceptability of monitoring strategies

Queen Mary, University of London0 sites1,000 target enrollmentJune 7, 2011

Overview

Registry

who.int

Start Date

June 7, 2011

End Date

May 31, 2015

Last Updated

7 years ago

Study Type

Interventional

Sex

Female

Sponsor

•1\. Have signed a consent form before undergoing any trial\-related activities
•2\. Have a confirmed viable pregnancy of less than 16 weeks gestation at booking
•3\. Have a confirmed diagnosis of epilepsy (any syndrome: primary, localised or unclassified)
•4\. Currently prescribed lamotrigine monotherapy or polytherapy (with carbamazepine, phenytoin or levetiracetam), carbamazepine monotherapy, phenytoin monotherapy or levetiracetam monotherapy
•5\. Be capable of understanding the information provided, with use of an interpreter if required

•1\. Be beyond 16 weeks gestation at booking
•2\. Documented non\-epileptic seizures in the last 2 years
•3\. Documented of status epilepticus in the last 12 months
•4\. A history of alcohol or substance abuse or dependence in the last 2 years
•5\. Sodium valproate (VPA) monotherapy or polytherapy
•6\. Non lamotrigine polytherapy
•7\. A history of poor AED adherence
•8\. Unable to complete a seizure diary or recall frequency of seizures accurately
•9\. Have a significant learning disability
•10\. Participation in any blinded, placebo\-controlled trials of investigational medicinal products in pregnancy