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Lamotrigine Pregnancy Registry (LAM05)

NCT01064297 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3416

Last updated 2013-02-25

Study results available
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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.

Conditions

Interventions

DRUG

Lamotrigine monotherapy

Lamotrigine monotherapy

DRUG

Lamotrigine polytherapy including valproate

Lamotrigine polytherapy including valproate

DRUG

Lamotrigine polytherapy without valproate

Lamotrigine polytherapy without valproate

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064297 on ClinicalTrials.gov