Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures
1 other identifier
interventional
141
4 countries
87
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2000
Longer than P75 for phase_4
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 14, 2002
CompletedFirst Posted
Study publicly available on registry
August 16, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedApril 4, 2017
March 1, 2017
2.9 years
August 14, 2002
March 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% change from Baseline in average monthly PGTC seizure frequency
Secondary Outcomes (1)
Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
Interventions
Eligibility Criteria
You may qualify if:
- Weigh at least 13kg.
- 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.
You may not qualify if:
- A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (87)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Mobile, Alabama, 36693, United States
GSK Investigational Site
Northport, Alabama, 35476, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Bakersfield, California, 93309, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
Northridge, California, 91325, United States
GSK Investigational Site
Sacramento, California, 95871, United States
GSK Investigational Site
Denver, Colorado, 80218, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Gainsville, Florida, 32611, United States
GSK Investigational Site
Miami, Florida, 33125, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Orlando, Florida, 32835, United States
GSK Investigational Site
Panama City, Florida, 32405, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33607-6350, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Boise, Idaho, 83712, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Chicago, Illinois, 60637-1470, United States
GSK Investigational Site
Springfield, Illinois, 62702, United States
GSK Investigational Site
Indianapolis, Indiana, 46202 - 5111, United States
GSK Investigational Site
Wichita, Kansas, 67214, United States
GSK Investigational Site
Crestview Hills, Kentucky, 41017, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Lexington, Kentucky, 40536-0284, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Newton, Massachusetts, 02459, United States
GSK Investigational Site
Sharon, Massachusetts, 02067, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Farmington Hills, Michigan, 48334, United States
GSK Investigational Site
Minneapolis, Minnesota, 55422, United States
GSK Investigational Site
Saint Cloud, Minnesota, 56303, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63110-1093, United States
GSK Investigational Site
Las Vegas, Nevada, 89102, United States
GSK Investigational Site
Cherry Hill, New Jersey, 8034, United States
GSK Investigational Site
Medford, New Jersey, 08055, United States
GSK Investigational Site
New Brunswick, New Jersey, 8903, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
Mount Vernon, New York, 10550, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Medford, Oregon, 97504-8456, United States
GSK Investigational Site
Portland, Oregon, 97201-2984, United States
GSK Investigational Site
Danville, Pennsylvania, 17822-4201, United States
GSK Investigational Site
Natrona Heights, Pennsylvania, 15065, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Germantown, Tennessee, 38138, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Nashville, Tennessee, 37212, United States
GSK Investigational Site
Arlington, Texas, 76015, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Salt Lake City, Utah, 84102, United States
GSK Investigational Site
Salt Lake City, Utah, 84113, United States
GSK Investigational Site
Bennington, Vermont, 05201, United States
GSK Investigational Site
Danville, Virginia, 24541, United States
GSK Investigational Site
Newport News, Virginia, 23601, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Madison, Wisconsin, 53715, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, 1181, Argentina
GSK Investigational Site
Buenos Aires, Buenos Aires, 1221, Argentina
GSK Investigational Site
Buenos Aires, Buenos Aires, C1428AQK, Argentina
GSK Investigational Site
Capital Federal, Argentina
GSK Investigational Site
Valparaíso, Región de Valparaíso, 2341131, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
San Isidro, Lima region, Lima 27, Peru
Related Publications (1)
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.
PMID: 16344515RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2002
First Posted
August 16, 2002
Study Start
December 1, 2000
Primary Completion
November 1, 2003
Study Completion
March 1, 2005
Last Updated
April 4, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.