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Pediatric Epilepsy Study in Subjects 1-24 Months

NCT ID: NCT00044278

Last Updated: 2017-01-18

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

Clinical Phase

PHASE2

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-06-30

Brief Summary

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This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

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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

Interventions

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lamotrigine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
* A confident diagnosis of epilepsy.
* 4 or more partial seizures per month.
* current treatment with 1 or 2 anti-epileptic drugs.

Exclusion Criteria

* Has seizures not related to epilepsy.
* Has a surgically implanted and functioning vagal nerve stimulator.
* Has previously been treated with lamotrigine.
* Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
* Use of experimental medication within 30 days of enrollment.
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

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

Mobile, Alabama, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Stanford, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Lexington, Kentucky, United States

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Saint Paul, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Cherry Hill, New Jersey, United States

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Buffalo, New York, United States

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Mineola, New York, United States

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Syracuse, New York, United States

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Chapel Hill, North Carolina, United States

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Raleigh, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Morristown, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Capital Federal, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Parkville, Melbourne, Victoria, Australia

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Tartu, , Estonia

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Reims, , France

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Budapest, , Hungary

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Debrecen, , Hungary

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Miskolc, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Napoli, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Mantova, Lombardy, Italy

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Milan, Lombardy, Italy

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Messina, Sicily, Italy

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Padua, Veneto, Italy

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Riga, , Latvia

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Beirut, , Lebanon

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Kaunas, , Lithuania

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Groningen, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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SanJuan, Puerto Rico, Puerto Rico

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Bratislava, , Slovakia

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Prešov, , Slovakia

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Ankara, , Turkey (Türkiye)

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Countries

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United States Argentina Australia Estonia France Hungary Italy Latvia Lebanon Lithuania Netherlands Portugal Puerto Rico Slovakia Turkey (Türkiye)

Study Documents

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Document Type: Annotated Case Report Form

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: Dataset Specification

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: Study Protocol

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

View Document

Document Type: Statistical Analysis Plan

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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LAM20007

Identifier Type: -

Identifier Source: org_study_id

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