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Drug Use Investigation for LAMICTAL

NCT ID: NCT01376180

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects prescribed lamotrigine tablet

Subjects with epilepsy prescribed lamotrigine tablet during study period

Lamotrigine

Intervention Type DRUG

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

Interventions

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Lamotrigine

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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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.

Reference Type BACKGROUND

Other Identifiers

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112727

Identifier Type: -

Identifier Source: org_study_id