NCT01376180

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

7.7 years

First QC Date

June 16, 2011

Last Update Submit

November 8, 2016

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

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

    6 months

Study Arms (1)

Subjects prescribed lamotrigine tablet

Subjects with epilepsy prescribed lamotrigine tablet during study period

Drug: Lamotrigine

Interventions

LamotrigineDRUG

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

Subjects prescribed lamotrigine tablet

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with epilepsy having the following seizure types. * partial seizures (including secondary generalized seizures) * tonic-clonic seizures * generalized seizures of Lennox-Gastaut syndrome

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

December 1, 2008

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11