Drug Use Investigation for LAMICTAL

The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.

Completed

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with epilepsy having the following seizure types.
Partial seizures (including secondary generalized seizures)
Tonic-clonic seizures
Generalized seizures of Lennox-Gastaut syndrome

Exclusion criteria

None

Treatment and study plan

Lamotrigine

Drug

Administered according to the prescribing information in the locally approved label by the authorities

Primary outcomes

The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2016
First posted: Jun 20, 2011
Registry last updated: Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed