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Special Drug Use Investigation for LAMICTAL® (Long Term)

NCT ID: NCT01863602

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

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-07-31

Brief Summary

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The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.

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 tablets

Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.

Lamotrigine tablets

Intervention Type DRUG

Administered for long-term according to the prescribing information in the locally approved label by the authorities.

Interventions

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Lamotrigine tablets

Administered for long-term 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 with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
* Subjects who are treated with lamotrigine tablets

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

Other Identifiers

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112728

Identifier Type: -

Identifier Source: org_study_id