Drug Use Investigation for LAMICTAL | NCT01376180

Studies
Drug Use Investigation for LAMICTAL

NCT01376180

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 9, 2016Estimated

Enrollment

3,000Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Lamotrigine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jun 16, 2011

First Submission Date that Met QC Criteria

Jun 16, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2016

Last Update Posted Date

Nov 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects prescribed lamotrigine tablet		Subjects with epilepsy prescribed lamotrigine tablet during study period	Drug: Lamotrigine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lamotrigine	Drug	Administered according to the prescribing information in the locally approved label by the authorities	Subjects prescribed lamotrigine tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D014227	Triazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds