Pediatric Epilepsy Trial in Subjects 1-24 Months

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 14, 2002
Last updated: August 19, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Drug: lamotrigine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in the time to escape patterns between LAMICTAL and placebo [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving a reduction in monthly partial seizure frequency from baseline between 40%-80% at the end of the Open-Label Phase [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Percent change from baseline in seizure frequency at the end of the Open-Label Phase by seizure type [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • The investigators' global evaluation of the subjects' status at the end of the Open-Label and Double-Blind Phases [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter assessment - Maximum Plasma Concentration (Cmax) [ Time Frame: Week 5 (before dose and at 1, 2, 3, 4, 6 and 8 hours after dose) ] [ Designated as safety issue: No ]
  • The incidence of adverse events over the course of the study [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • The change from baseline in clinical laboratory and vital sign values [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter assessment - Area Under the Curve (AUC) [ Time Frame: Week 5 (before dose and at 1, 2, 3, 4, 6 and 8 hours after dose) ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter assessment - CL/F (Oral clearance) [ Time Frame: Week 5 (before dose and at 1, 2, 3, 4, 6 and 8 hours after dose) ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: May 2000
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   1 Month to 24 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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)


  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00043875

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United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90027
GSK Investigational Site
Stanford, California, United States, 94305-5235
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80218
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
GSK Investigational Site
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
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55102-2383
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64108
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
GSK Investigational Site
Columbus, Ohio, United States, 43205
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97227
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Tartu, Estonia, 51014
GSK Investigational Site
Riga, Latvia, LV 1004
GSK Investigational Site
Beirut, Lebanon, 11072020
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
GSK Investigational Site
Ankara, Turkey
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00043875     History of Changes
Other Study ID Numbers: LAM20006 
Study First Received: August 14, 2002
Last Updated: August 19, 2015
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
partial seizures

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on August 25, 2016