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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00044278 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: lamotrigine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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) |
| Enrollment: | 225 |
| Study Start Date: | September 2000 |
Eligibility| Ages Eligible for Study: | 1 Month to 24 Months |
| 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 | |
| Mobile, Alabama, United States, 36693 | |
| United States, Arizona | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72202 | |
| GSK Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| GSK Investigational Site | |
| Stanford, California, United States, 94305-5235 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90027 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90095 | |
| 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 | |
| Miami, Florida, United States, 33155-3009 | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33609 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32207 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32835 | |
| 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 | |
| Columbia, Missouri, United States, 65211 | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Cherry Hill, New Jersey, United States, 8034 | |
| United States, New York | |
| GSK Investigational Site | |
| Mineola, New York, United States, 11501 | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14222 | |
| GSK Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43205 | |
| GSK Investigational Site | |
| Akron, Ohio, United States, 44308-1062 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97201-2884 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97201-2984 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15213-2583 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Morristown, Tennessee, United States, 37813 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| United States, Utah | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23507 | |
| GSK Investigational Site | |
| Charlottesville, Virginia, United States, 22908 | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23298 | |
| Argentina | |
| GSK Investigational Site | |
| Ciudad Autónoma de Buenos Aires, Argentina, 1425 | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, 1181 | |
| Australia, Queensland | |
| GSK Investigational Site | |
| Brisbane, Queensland, Australia | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Parkville, Melbourne, Victoria, Australia, 3050 | |
| Estonia | |
| GSK Investigational Site | |
| Tartu, Estonia, 51014 | |
| France | |
| GSK Investigational Site | |
| Reims Cedex, France, 51092 | |
| Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1094 | |
| GSK Investigational Site | |
| Miskolc, Hungary, 3526 | |
| GSK Investigational Site | |
| Pécs, Hungary, 7623 | |
| GSK Investigational Site | |
| Szeged, Hungary, 6720 | |
| GSK Investigational Site | |
| Debrecen, Hungary, 4012 | |
| Italy, Campania | |
| GSK Investigational Site | |
| Napoli, Campania, Italy, 80131 | |
| Italy, Emilia-Romagna | |
| GSK Investigational Site | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Italy, Lombardia | |
| GSK Investigational Site | |
| Milano, Lombardia, Italy, 20133 | |
| GSK Investigational Site | |
| Mantova, Lombardia, Italy, 46100 | |
| Italy, Sicilia | |
| GSK Investigational Site | |
| Messina, Sicilia, Italy, 98125 | |
| Italy, Veneto | |
| GSK Investigational Site | |
| Padova, Veneto, Italy, 35128 | |
| Latvia | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1004 | |
| Lebanon | |
| GSK Investigational Site | |
| Beirut, Lebanon, 11072020 | |
| Lithuania | |
| GSK Investigational Site | |
| Kaunas, Lithuania, LT-50009 | |
| Netherlands | |
| GSK Investigational Site | |
| UTRECHT, Netherlands, 3584 EA | |
| GSK Investigational Site | |
| ROTTERDAM, Netherlands, 3015 GD | |
| GSK Investigational Site | |
| GRONINGEN, Netherlands, 9713 GZ | |
| Portugal | |
| GSK Investigational Site | |
| Coimbra, Portugal, 3000-075 | |
| GSK Investigational Site | |
| Lisboa, Portugal, 1150 | |
| GSK Investigational Site | |
| Porto, Portugal, 4099-001 | |
| Puerto Rico | |
| GSK Investigational Site | |
| SanJuan, Puerto Rico, 00936 | |
| Slovakia | |
| GSK Investigational Site | |
| Presov, Slovakia, 080 01 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 833 40 | |
| Turkey | |
| GSK Investigational Site | |
| Ankara, Turkey | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | LAM20007 |
| Study First Received: | August 23, 2002 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044278 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Lithuania: State Medicine Control Agency - Ministry of Health |
|
epilepsy partial seizures pediatric |
|
Molecular Mechanisms of Pharmacological Action Nervous System Diseases Central Nervous System Diseases Calcium Channel Blockers Cardiovascular Agents Brain Diseases Pharmacologic Actions |
Membrane Transport Modulators Epilepsy Therapeutic Uses Lamotrigine Central Nervous System Agents Anticonvulsants |
