Pediatric Epilepsy Trial in Subjects 1-24 Months
A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)
1 other identifier
interventional
177
13 countries
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2000
Typical duration for phase_2
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 14, 2002
CompletedFirst Posted
Study publicly available on registry
August 15, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedSeptember 15, 2016
September 1, 2016
3.5 years
August 14, 2002
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.
36 Months
Secondary Outcomes (1)
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
36 Months
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (65)
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
Los Angeles, California, 90027, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Stanford, California, 94305-5235, United States
GSK Investigational Site
Denver, Colorado, 80218, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Miami, Florida, 33155-3009, United States
GSK Investigational Site
Orlando, Florida, 32835, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33607-6350, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Lexington, Kentucky, 40536-0284, United States
GSK Investigational Site
Saint Paul, Minnesota, 55102-2383, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Cherry Hill, New Jersey, 8034, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Akron, Ohio, 44308-1062, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Columbus, Ohio, 43205, United States
GSK Investigational Site
Portland, Oregon, 97227, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213-2583, United States
GSK Investigational Site
Nashville, Tennessee, 37212, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Charlottesville, Virginia, 22908, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Richmond, Virginia, 23298, United States
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Parkville, Melbourne, Victoria, 3050, Australia
GSK Investigational Site
West Heidleberg, Melbourne, Victoria, Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Reims, 51092, France
GSK Investigational Site
Budapest, 1094, Hungary
GSK Investigational Site
Debrecen, 4012, Hungary
GSK Investigational Site
Miskolc, 3526, Hungary
GSK Investigational Site
Szeged, 6720, Hungary
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, 40138, Italy
GSK Investigational Site
Mantova, Lombardy, 46100, Italy
GSK Investigational Site
Milan, Lombardy, 20133, Italy
GSK Investigational Site
Messina, Sicily, 98125, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Riga, LV 1004, Latvia
GSK Investigational Site
Beirut, 11072020, Lebanon
GSK Investigational Site
Kaunas, LT-50009, Lithuania
GSK Investigational Site
Groningen, 9713 GZ, Netherlands
GSK Investigational Site
Rotterdam, 3015 GD, Netherlands
GSK Investigational Site
Utrecht, 3584 EA, Netherlands
GSK Investigational Site
Coimbra, 3000-075, Portugal
GSK Investigational Site
Lisbon, 1150, Portugal
GSK Investigational Site
Porto, 4099-001, Portugal
GSK Investigational Site
Banská Bystrica, 975 17, Slovakia
GSK Investigational Site
Bratislava, 833 40, Slovakia
GSK Investigational Site
Prešov, 080 01, Slovakia
GSK Investigational Site
Las Palmas de Gran Canaria, 35016, Spain
GSK Investigational Site
Ankara, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2002
First Posted
August 15, 2002
Study Start
May 1, 2000
Primary Completion
November 1, 2003
Study Completion
November 1, 2003
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.