NCT01863602

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

7.3 years

First QC Date

October 4, 2012

Last Update Submit

November 8, 2016

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

  • The incidence of adverse drug reactions

    1 year

  • Occurrence of skin disorder after the start of treatment

    Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item

    1 year

Secondary Outcomes (1)

  • Overall improvement of subjects' symptoms

    1 year

Study Arms (1)

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.

Drug: Lamotrigine tablets

Interventions

Lamotrigine tabletsDRUG

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

Subjects prescribed lamotrigine tablets

Eligibility Criteria

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

Adult (\>=15 to \<65 years) and pediatric (\>=2 to \<15 years) subjects with epilepsy with the following seizure type who use lamotrigine tablets * Partial seizures * Tonic-clonic seizures * Generalized seizures of Lennox-Gastaut syndrome

You may qualify if:

  • Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
  • Subjects who are treated with lamotrigine tablets

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

October 4, 2012

First Posted

May 29, 2013

Study Start

April 1, 2009

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11