Study Results
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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COMPLETED
PHASE2
177 participants
INTERVENTIONAL
2000-05-31
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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lamotrigine
Eligibility Criteria
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Inclusion Criteria
* 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 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).
1 Month
24 Months
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Stanford, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Tallahassee, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Saint Paul, Minnesota, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Cherry Hill, New Jersey, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Akron, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
South Brisbane, Queensland, Australia
GSK Investigational Site
Parkville, Melbourne, Victoria, Australia
GSK Investigational Site
West Heidleberg, Melbourne, Victoria, Australia
GSK Investigational Site
Perth, Western Australia, Australia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Reims, , France
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Debrecen, , Hungary
GSK Investigational Site
Miskolc, , Hungary
GSK Investigational Site
Szeged, , Hungary
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy
GSK Investigational Site
Mantova, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Messina, Sicily, Italy
GSK Investigational Site
Padua, Veneto, Italy
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
Beirut, , Lebanon
GSK Investigational Site
Kaunas, , Lithuania
GSK Investigational Site
Groningen, , Netherlands
GSK Investigational Site
Rotterdam, , Netherlands
GSK Investigational Site
Utrecht, , Netherlands
GSK Investigational Site
Coimbra, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Banská Bystrica, , Slovakia
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Prešov, , Slovakia
GSK Investigational Site
Las Palmas de Gran Canaria, , Spain
GSK Investigational Site
Ankara, , Turkey (Türkiye)
Countries
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Study Documents
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Document Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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LAM20006
Identifier Type: -
Identifier Source: org_study_id
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