|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00043901 |
Purpose
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: lamotrigine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study |
| Official Title: | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures |
| Estimated Enrollment: | 104 |
| Study Start Date: | December 2000 |
Eligibility| Ages Eligible for Study: | 2 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 | |
| Mobile, Alabama, United States, 36693 | |
| GSK Investigational Site | |
| Alabaster, Alabama, United States, 35007 | |
| GSK Investigational Site | |
| Northport, Alabama, United States, 35476 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| Sacramento, California, United States, 95871 | |
| GSK Investigational Site | |
| Irvine, California, United States, 92618 | |
| GSK Investigational Site | |
| Northridge, California, United States, 91325 | |
| GSK Investigational Site | |
| Bakersfield, California, United States, 93309 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Delaware | |
| GSK Investigational Site | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| GSK Investigational Site | |
| Panama City, Florida, United States, 32405 | |
| GSK Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33607-6350 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32835 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33125 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| Gainsville, Florida, United States, 32611 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30338 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| GSK Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| United States, Idaho | |
| GSK Investigational Site | |
| Idaho Falls, Idaho, United States, 83404 | |
| GSK Investigational Site | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637-1470 | |
| GSK Investigational Site | |
| Springfield, Illinois, United States, 62702 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 - 5111 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40503 | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Newton, Massachusetts, United States, 02459 | |
| GSK Investigational Site | |
| Sharon, Massachusetts, United States, 02067 | |
| GSK Investigational Site | |
| Newton, Massachusetts, United States, 02459 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Farmington Hills, Michigan, United States, 48334 | |
| GSK Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55422 | |
| GSK Investigational Site | |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Springfield, Missouri, United States, 65807 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63110-1093 | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| New Brunswick, New Jersey, United States, 8903 | |
| GSK Investigational Site | |
| Medford, New Jersey, United States, 08055 | |
| GSK Investigational Site | |
| Cherry Hill, New Jersey, United States, 8034 | |
| United States, New York | |
| GSK Investigational Site | |
| Albany, New York, United States, 12205 | |
| GSK Investigational Site | |
| Mount Vernon, New York, United States, 10550 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Greenville, North Carolina, United States, 27834 | |
| GSK Investigational Site | |
| Asheville, North Carolina, United States, 28801 | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28207 | |
| GSK Investigational Site | |
| Winston-Salem, North Carolina, United States, 27157 | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Toledo, Ohio, United States, 43614-5809 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| GSK Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97201-2984 | |
| GSK Investigational Site | |
| Medford, Oregon, United States, 97504-8456 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Natrona Heights, Pennsylvania, United States, 15065 | |
| GSK Investigational Site | |
| Danville, Pennsylvania, United States, 17822-4201 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Germantown, Tennessee, United States, 38138 | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37212 | |
| GSK Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Arlington, Texas, United States, 76015 | |
| United States, Utah | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84102 | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Vermont | |
| GSK Investigational Site | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Danville, Virginia, United States, 24541 | |
| GSK Investigational Site | |
| Newport News, Virginia, United States, 23601 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| GSK Investigational Site | |
| Marshfield, Wisconsin, United States, 54449 | |
| GSK Investigational Site | |
| Madison, Wisconsin, United States, 53715 | |
| Argentina | |
| GSK Investigational Site | |
| Capital Federal, Argentina | |
| GSK Investigational Site | |
| Buenos Aires, Argentina, C1428AQK | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | |
| ., Buenos Aires, Argentina, 1221 | |
| GSK Investigational Site | |
| ., Buenos Aires, Argentina, 1181 | |
| Chile, Región Metro De Santiago | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile | |
| Chile, Valparaíso | |
| GSK Investigational Site | |
| Valparaiso, Valparaíso, Chile, 2352499 | |
| Peru, Lima | |
| GSK Investigational Site | |
| San Isidro, Lima, Peru, Lima 27 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | LAM40097 |
| Study First Received: | August 14, 2002 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00043901 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
Lamotrigine epilepsy primary generalized tonic-clonic PGTC seizures |
|
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 |