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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00113165 |
Purpose
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: LAMICTAL extended-release |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures |
| Estimated Enrollment: | 204 |
| Study Start Date: | October 2004 |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| GSK Investigational Site | |
| Birmingham, Alabama, United States, 35294-0021 | |
| GSK Investigational Site | |
| Anniston, Alabama, United States, 36207 | |
| GSK Investigational Site | |
| Northport, Alabama, United States, 35476 | |
| United States, Arizona | |
| GSK Investigational Site | |
| Mesa, Arizona, United States, 85201 | |
| GSK Investigational Site | |
| Sun City, Arizona, United States, 85351 | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| Newport Beach, California, United States, 92660 | |
| GSK Investigational Site | |
| Santa Monica, California, United States, 90404 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90073 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| GSK Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Springfield, Illinois, United States, 62702 | |
| GSK Investigational Site | |
| Flossmoor, Illinois, United States, 60422 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Crestview Hills, Kentucky, United States, 41017 | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40536-0284 | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| GSK Investigational Site | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55454 | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55422 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Chesterfield, Missouri, United States, 63017 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89103 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Asheville, North Carolina, United States, 28801 | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43210-1250 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| GSK Investigational Site | |
| Galveston, Texas, United States, 77555 | |
| GSK Investigational Site | |
| Wichita Falls, Texas, United States, 76301 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77005 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23220 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98122-4358 | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, 1181 | |
| Brazil, Paraná | |
| GSK Investigational Site | |
| Curitiba, Paraná, Brazil, 80069-900 | |
| Chile, Región Metro De Santiago | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7571831 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 10969 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22083 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22527 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22523 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Fuerth, Bayern, Germany, 90762 | |
| GSK Investigational Site | |
| Alzenau, Bayern, Germany, 63755 | |
| Germany, Brandenburg | |
| GSK Investigational Site | |
| Ludwigsfelde, Brandenburg, Germany, 14974 | |
| Germany, Hessen | |
| GSK Investigational Site | |
| Bad Homburg, Hessen, Germany, 61348 | |
| Germany, Mecklenburg-Vorpommern | |
| GSK Investigational Site | |
| Wismar, Mecklenburg-Vorpommern, Germany, 23970 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Koeln, Nordrhein-Westfalen, Germany, 50672 | |
| GSK Investigational Site | |
| Koeln, Nordrhein-Westfalen, Germany, 50767 | |
| GSK Investigational Site | |
| Muenster, Nordrhein-Westfalen, Germany, 48149 | |
| Germany, Rheinland-Pfalz | |
| GSK Investigational Site | |
| Limburgerhof, Rheinland-Pfalz, Germany, 67117 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Radeberg, Sachsen, Germany, 01465 | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04105 | |
| Germany, Sachsen-Anhalt | |
| GSK Investigational Site | |
| Naumburg, Sachsen-Anhalt, Germany, 06618 | |
| Germany, Thueringen | |
| GSK Investigational Site | |
| Jena-Lobeda, Thueringen, Germany, 07747 | |
| India | |
| GSK Investigational Site | |
| Lucknow, India, 226003 | |
| GSK Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500482 | |
| GSK Investigational Site | |
| New Delhi, India | |
| Puerto Rico | |
| GSK Investigational Site | |
| San German, Puerto Rico, 00683 | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00918 | |
| Russian Federation | |
| GSK Investigational Site | |
| Ekaterinburg, Russian Federation, 620102 | |
| GSK Investigational Site | |
| St.-Petersburg, Russian Federation, 197376 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 117049 | |
| GSK Investigational Site | |
| St.-Petersburg, Russian Federation, 193019 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 127473 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 107076 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 125412 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 111539 | |
| Ukraine | |
| GSK Investigational Site | |
| Kyiv, Ukraine, 02660 | |
| GSK Investigational Site | |
| Kharkiv, Ukraine, 61068 | |
| GSK Investigational Site | |
| Lviv, Ukraine, 79021 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | LAM100034 |
| Study First Received: | June 6, 2005 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00113165 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation; Germany: Federal Institute for Drugs and Medical Devices; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; South Korea: Korea Food and Drug Administration (KFDA); India: Indian Council of Medical Research |
|
Epilepsy partial seizures seizures lamotrigine |
anticonvulsants antiepileptic drugs LAMICTAL |
|
Molecular Mechanisms of Pharmacological Action Seizures Nervous System Diseases Central Nervous System Diseases Calcium Channel Blockers Cardiovascular Agents Brain Diseases Pharmacologic Actions |
Membrane Transport Modulators Signs and Symptoms Epilepsy Therapeutic Uses Lamotrigine Neurologic Manifestations Central Nervous System Agents Anticonvulsants |
