Pediatric Epilepsy Study in Subjects 1-24 Months

An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: lamotrigine

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aires, Argentina, 1425
    • GSK Investigational Site
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1181
      • GSK Investigational Site
• Australia
  • Victoria
    • Parkville, Melbourne, Victoria, Australia, 3050
      • GSK Investigational Site
• Estonia
  • 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
  • Pécs, Hungary, 7623
    • 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
• Puerto Rico
  • SanJuan, Puerto Rico, 00936
    • GSK Investigational Site
• Slovakia
  • Bratislava, Slovakia, 833 40
    • GSK Investigational Site
  • Presov, Slovakia, 080 01
    • GSK Investigational Site
• Turkey
  • Ankara, Turkey
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • GSK Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85712
      • GSK Investigational Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
    • 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, 33609
      • 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
    • Columbia, Missouri, United States, 65211
      • GSK Investigational Site
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 8034
      • GSK Investigational Site
  • New York
    • Buffalo, New York, United States, 14222
      • GSK Investigational Site
    • Mineola, New York, United States, 11501
      • GSK Investigational Site
    • 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, 97201-2884
      • GSK Investigational Site
    • Portland, Oregon, United States, 97201-2984
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-2583
      • GSK Investigational Site
  • Tennessee
    • Morristown, Tennessee, United States, 37813
      • GSK Investigational Site
    • 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
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • GSK Investigational Site
    • Norfolk, Virginia, United States, 23507
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23298
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation	43 Months
Change from baseline in vital signs -heart rate (HR)	Up to 43 Months
Change from baseline in vital signs - weight (WT)	Up to 43 months
Change from baseline in vital signs - height (HT)	Up to 43 months
Change from baseline in vital signs - head circumference (HC)	Up to 43 months
Change from baseline in clinical chemistry parameters including Albumin and Total protein	Up to month 43
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)	Up to 43 moths
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine	Up to 43 months
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea	Up to 43 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)	Up to 43 moths
Change from baseline in Hemoglobin (Hb)	Up to 43 months
Change from baseline in Mean corpuscular hemoglobin (MCH)	Up to 43 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)	Up to 43 months
Change from baseline in mean corpuscular volume (MCv)	Up to 43 months
Change from baseline in red blood cells (RBC)	Up to 43 months
Number of participants with treatment emergent neurological abnormalities	Up to 43 months
Number of participants with treatment emergent clinically significant ECG abnormalities	Up to 43 months
Number of participants with potentially clinically significant change in hematology parameters	Up to 43 months
Number of participants with potentially clinically significant change in clinical chemistry parameters	Up to 43 months
Number of participants with potentially clinically significant change in vital signs	Up to 43 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase	Up to 48 Weeks
Investigator's assessment of the participant's overall clinical status	Up to 43 months
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants	Week 6

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: August 23, 2002
• First Submitted That Met QC Criteria: August 23, 2002
• First Posted (Estimate): August 26, 2002

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: pediatric; epilepsy; partial seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Lamotrigine
• Other Study ID Numbers: LAM20007

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. Annotated Case Report Form
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: LAM20007
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register