Antiepileptic drug monitoring In pregnancy

Not Applicable

Completed

• Conditions: Epilepsy in pregnancy; Nervous System Diseases; Epilepsy

• Registration Number: ISRCTN01253916
• Lead Sponsor: Queen Mary, University of London

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29737274

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-07
• Study Completion: 2015-05-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from randomisation to first seizure and time to first tonic clonic seizure throughout pregnancy up to and including six weeks post-delivery. Statistical analysis will take into account the time to each ?event? per woman over the whole period of monitoring. Participants will be asked to document the occurrence of each seizure by frequency and type in a trial specific seizure diary.