Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
NCT ID: NCT00043901
Last Updated: 2017-04-04
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
PHASE4
141 participants
INTERVENTIONAL
2000-12-01
2005-03-01
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
* Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
* Currently being treated with an antiepileptic drug(s) (AED).
* Benzodiazepines are allowed with some frequency restrictions.
* Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
* History of primary generalized tonic-clonic seizures with no focal onset.
* Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
* Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
* Females must agree to acceptable form of birth control.
Exclusion Criteria
* Have Lennox-Gastaut syndrome.
* Currently using or has previously used the drug being studied.
* Is abusing alcohol and/or other substance(s).
* Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
* Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
* Follows the ketogenic diet.
* Is planning surgery to control seizures during the study.
* Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
* Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
2 Years
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
Alabaster, Alabama, United States
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Mobile, Alabama, United States
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Northport, Alabama, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Irvine, California, United States
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Northridge, California, United States
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Sacramento, California, United States
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Denver, Colorado, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Gainsville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Crestview Hills, Kentucky, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Newton, Massachusetts, United States
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Sharon, Massachusetts, United States
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Detroit, Michigan, United States
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Farmington Hills, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Medford, New Jersey, United States
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New Brunswick, New Jersey, United States
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Albany, New York, United States
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Mount Vernon, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Danville, Pennsylvania, United States
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Natrona Heights, Pennsylvania, United States
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Spartanburg, South Carolina, United States
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Germantown, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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Bennington, Vermont, United States
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Danville, Virginia, United States
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Newport News, Virginia, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Marshfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, , Argentina
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Valparaíso, Región de Valparaíso, Chile
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Santiago, Región Metro de Santiago, Chile
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San Isidro, Lima region, Peru
Countries
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References
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Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005 Dec 13;65(11):1737-43. doi: 10.1212/01.wnl.0000187118.19221.e4.
Study Documents
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Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
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: 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 DocumentDocument Type: Study Protocol
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 DocumentRelated Links
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Other Identifiers
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LAM40097
Identifier Type: -
Identifier Source: org_study_id
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