CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,416 enrolled
Drug / intervention
Lamotrigine monotherapy +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01064297
NCT01064297N/ACompleted
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Lamotrigine Pregnancy Registry (LAM05)

GlaxoSmithKline·observational·Posted Feb 8, 2010·Updated Feb 25, 2013

In Brief

An observational study evaluating Lamotrigine monotherapy, Lamotrigine polytherapy including valproate, and 1 other intervention for Epilepsy and Bipolar Disorder. Completed, enrolled 3,416 participants.

Detailed Summary

Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with epilepsy, and other approved indications including bipolar disorder, may require or be unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992 to monitor the safety of lamotrigine during pregnancy.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Bipolar Disorder
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2010
Enrollment StartNov 1, 2001
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 16.4 years ago

Interventions

Lamotrigine monotherapydrug

Lamotrigine monotherapy

Lamotrigine polytherapy including valproatedrug

Lamotrigine polytherapy including valproate

Lamotrigine polytherapy without valproatedrug

Lamotrigine polytherapy without valproate