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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00355082 |
Purpose
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy, Partial |
Drug: lamotrigine, 250 mg/day Drug: lamotrigine, 300 mg/day |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures |
| Enrollment: | 226 |
| Study Start Date: | May 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Historic data: Experimental
The Historic Control is based on aggregated data from 8 similarly-conducted studies. Historic data will serve as the control for both treatment arms in this study.
|
Drug: lamotrigine, 250 mg/day
250 mg/day
Drug: lamotrigine, 300 mg/day
300 mg/day
|
The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
NOTE: With prior authorization from GlaxoSmithKline (GSK), retrospective data may take the place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase for subjects providing reliable documentation of the following:
All subjects permitted to use retrospective baseline data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus the prospective Baseline Phases must equal the 56 consecutive days prior to the start of dosing with study drug.
if female, and of childbearing potential be using an acceptable form of birth control, to include one of the following:
Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.
Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm).
NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are considered to be of non-childbearing potential.
NOTE: A pharmacokinetic interaction has been observed between lamotrigine (LTG) and estrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e.g., for contraception or hormone replacement therapy) is not allowed.
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| GSK Investigational Site | |
| Alabaster, Alabama, United States, 35007 | |
| United States, Arizona | |
| GSK Investigational Site | |
| Litchfield Park, Arizona, United States, 85340 | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85724 | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85013 | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85741 | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85003 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90073 | |
| GSK Investigational Site | |
| Santa Ana, California, United States, 92705 | |
| GSK Investigational Site | |
| Pasadena, California, United States, 91105 | |
| GSK Investigational Site | |
| Santa Monica, California, United States, 90404 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Fairfield, Connecticut, United States, 06824 | |
| GSK Investigational Site | |
| Danbury, Connecticut, United States, 06810 | |
| United States, Delaware | |
| GSK Investigational Site | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33613 | |
| GSK Investigational Site | |
| Loxahatchee, Florida, United States, 33470 | |
| GSK Investigational Site | |
| Sunrise, Florida, United States, 33351 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Idaho | |
| GSK Investigational Site | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| GSK Investigational Site | |
| Urbana, Illinois, United States, 61801 | |
| GSK Investigational Site | |
| Flossmoor, Illinois, United States, 60422 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| GSK Investigational Site | |
| Des Moines, Iowa, United States, 50309 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40513 | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Bethesda, Maryland, United States, 20817 | |
| GSK Investigational Site | |
| Glen Burnie, Maryland, United States, 21061 | |
| GSK Investigational Site | |
| Pikesville, Maryland, United States, 21208 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Springfield, Massachusetts, United States, 01104 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| GSK Investigational Site | |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Mississippi | |
| GSK Investigational Site | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Montana | |
| GSK Investigational Site | |
| St. Louis, Montana, United States, 63110 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Henderson, Nevada, United States, 89014 | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Edison, New Jersey, United States, 08818 | |
| GSK Investigational Site | |
| Vorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| GSK Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| GSK Investigational Site | |
| Plainview, New York, United States, 11803 | |
| GSK Investigational Site | |
| Lawrence, New York, United States, 11559 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Asheville, North Carolina, United States, 28803 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43210-1296 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Sellersville, Pennsylvania, United States, 18960 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77025 | |
| GSK Investigational Site | |
| Temple, Texas, United States, 76502 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78258 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| GSK Investigational Site | |
| Midvale, Utah, United States, 84047 | |
| United States, Washington | |
| GSK Investigational Site | |
| Renton, Washington, United States, 98055 | |
| United States, West Virginia | |
| GSK Investigational Site | |
| Morgantown, West Virginia, United States, 26506 | |
| GSK Investigational Site | |
| Charleston, West Virginia, United States, 25301 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Madison, Wisconsin, United States, 53715 | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Argentina | |
| GSK Investigational Site | |
| Ciudad Autonoma de Buenos Aires, Argentina | |
| GSK Investigational Site | |
| Ciudad Autónoma de Buenos Aires, Argentina, 1425 | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | |
| Capital Fefderal, Buenos Aires, Argentina | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, 1181 | |
| Chile, Región Metro De Santiago | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7560356 | |
| GSK Investigational Site | |
| Providencia / Santiago, Región Metro De Santiago, Chile, 7500710 | |
| Costa Rica | |
| GSK Investigational Site | |
| San Jose, Costa Rica | |
| Korea, Republic of | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 135-170 | |
| GSK Investigational Site | |
| Daegu, Korea, Republic of, 700-712 | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| GSK Investigational Site | |
| Daejeon, Korea, Republic of, 301-721 | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Puerto Rico | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00936 | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00918 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 117049 | |
| GSK Investigational Site | |
| Samara, Russian Federation, 443095 | |
| GSK Investigational Site | |
| St.-Petersburg, Russian Federation, 193019 | |
| GSK Investigational Site | |
| Ekaterinburg, Russian Federation, 620102 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 125412 | |
| GSK Investigational Site | |
| St.Petersburg, Russian Federation, 193167 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 105066 | |
| GSK Investigational Site | |
| St.-Petersburg, Russian Federation, 194291 | |
| Ukraine | |
| GSK Investigational Site | |
| Dnepropetrovsk, Ukraine, 49616 | |
| GSK Investigational Site | |
| Lugansk, Ukraine, 91045 | |
| GSK Investigational Site | |
| Zaporizhzhya, Ukraine, 69057 | |
| GSK Investigational Site | |
| Donetsk, Ukraine, 83037 | |
| GSK Investigational Site | |
| Kharkiv, Ukraine, 61068 | |
| GSK Investigational Site | |
| Vinnitsa, Ukraine, 21018 | |
| GSK Investigational Site | |
| Kyiv, Ukraine | |
| GSK Investigational Site | |
| Kyiv, Ukraine, 02660 | |
| GSK Investigational Site | |
| Lviv, Ukraine, 79021 | |
| GSK Investigational Site | |
| Odesa, Ukraine, 65006 | |
| GSK Investigational Site | |
| Poltava, Ukraine | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | LAM30055 |
| Study First Received: | July 19, 2006 |
| Results First Received: | September 8, 2009 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00355082 History of Changes |
| Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation; United States: Food and Drug Administration |
|
epilepsy monotherapy lamotrigine Lamictal |
|
Epilepsies, Partial 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 |