Pediatric Epilepsy Trial in Subjects 1-24 Months

September 13, 2016 updated by: GlaxoSmithKline

A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)

This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • GSK Investigational Site
    • Victoria
      • Parkville, Melbourne, Victoria, Australia, 3050
        • GSK Investigational Site
      • West Heidleberg, Melbourne, Victoria, Australia
        • GSK Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • France
      • Reims Cedex, France, 51092
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1094
        • GSK Investigational Site
      • Debrecen, Hungary, 4012
        • GSK Investigational Site
      • Miskolc, Hungary, 3526
        • GSK Investigational Site
      • Szeged, Hungary, 6720
        • GSK Investigational Site
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • GSK Investigational Site
    • Lombardia
      • Mantova, Lombardia, Italy, 46100
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20133
        • GSK Investigational Site
    • Sicilia
      • Messina, Sicilia, Italy, 98125
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1004
        • GSK Investigational Site
  • Lebanon
      • Beirut, Lebanon, 11072020
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3015 GD
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 EA
        • GSK Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • GSK Investigational Site
      • Lisboa, Portugal, 1150
        • GSK Investigational Site
      • Porto, Portugal, 4099-001
        • GSK Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • GSK Investigational Site
      • Bratislava, Slovakia, 833 40
        • GSK Investigational Site
      • Presov, Slovakia, 080 01
        • GSK Investigational Site
  • Spain
      • Las Palmas De Gran Canaria, Spain, 35016
        • GSK Investigational Site
  • Turkey
      • Ankara, Turkey
        • GSK Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • GSK Investigational Site
    • California
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site
      • Los Angeles, California, United States, 90027
        • GSK Investigational Site
      • Stanford, California, United States, 94305-5235
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • GSK Investigational Site
      • Miami, Florida, United States, 33155-3009
        • GSK Investigational Site
      • Orlando, Florida, United States, 32835
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Tampa, Florida, United States, 33607-6350
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • GSK Investigational Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55102-2383
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • GSK Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 8034
        • GSK Investigational Site
    • New York
      • Syracuse, New York, United States, 13210
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43205
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • GSK Investigational Site
      • Portland, Oregon, United States, 97227
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2583
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23510
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23298
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  • Have a confident diagnosis of epilepsy
  • Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
  • Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
  • Have no underlying chronic metabolism problems
  • Have normal lab results
  • Have a normal electrocardiogram (ECG)

EXCLUSION CRITERIA:

  • Have a diagnosis of severe, progressive myoclonus.
  • Have seizures not related to epilepsy.
  • Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
  • Have progressive or unstable condition of the nervous system.
  • Used experimental medication within 30 of enrollment into the study.
  • Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
  • Current use of the medication felbamate.
  • Current use of adrenocorticotrophic hormone (ACTH).
  • Following a ketogenic diet.
  • Receiving vagal nerve stimulation (VNS).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
Time Frame: 36 Months
36 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events
Time Frame: 36 Months
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

November 1, 2003

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

August 14, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM20006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: LAM20006
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on lamotrigine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe