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Lamotrigine Extended-Release In Elderly Patients With Epilepsy

NCT ID: NCT00516139

Last Updated: 2017-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-07-31

Brief Summary

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This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lamotrigine

Open-label lamotrigine

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

Open-label

Interventions

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Lamotrigine

Open-label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confident diagnosis of epilepsy
* Currently treated with one or two antiepileptic medications
* Able to complete a seizure diary

Exclusion Criteria

* History of hypersensitivity to lamotrigine
* Progressive diseases that would interfere with the study objectives
Minimum Eligible Age

65 Years

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

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Gilbert, Arizona, United States

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Litchfield Park, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Fresno, California, United States

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Fullteron, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Pasadena, California, United States

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Fort Collins, Colorado, United States

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Newark, Delaware, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Ponte Vedra Beach, Florida, United States

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Sarasota, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Suwanee, Georgia, United States

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Boise, Idaho, United States

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Springfield, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Scarborough, Maine, United States

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Burlington, Massachusetts, United States

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Hopedale, Massachusetts, United States

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Traverse City, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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Henderson, Nevada, United States

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Camden, New Jersey, United States

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Newark, New Jersey, United States

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Summit, New Jersey, United States

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Cedarhurst, New York, United States

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Rochester, New York, United States

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Schenectady, New York, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Columbia, Tennessee, United States

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Cordova, Tennessee, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Richmond, Virginia, United States

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Bremerton, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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LEP105972

Identifier Type: -

Identifier Source: org_study_id

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