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Drug Use Investigation for LAMICTAL

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Lamotrigine (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: Drug Use Investigation for LAMICTAL

Study design: Time Perspective: Prospective

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Related publications:

Sunao Kaneko, Yushi Inoue, Masafumi Iijima, Atsuko Ishida, Shogo Inoshiri. Drug Use Investigation of Lamotrigine Tablets in Patients with Epilepsy - Results of Interim Analysis -. 2011;60(3):9-35.

Starting date: December 2008
Last updated: April 16, 2015

Page last updated: August 23, 2015

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