Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures
1 other identifier
interventional
244
10 countries
148
Brief Summary
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Typical duration for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 6, 2005
CompletedFirst Posted
Study publicly available on registry
June 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 5, 2016
December 1, 2016
2.7 years
June 6, 2005
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.
24 Weeks
Secondary Outcomes (1)
Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics
24 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of epilepsy with partial seizures for more than 24 weeks.
- Must experience at least 8 partial seizures during an 8-week Baseline Phase.
- Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
- Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.
You may not qualify if:
- Previous treatment with lamotrigine.
- Exhibits any primary generalized seizures.
- Receiving treatment with felbamate or currently following the ketogenic diet.
- Pregnant, breastfeeding, or planning to become pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (148)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35294-0021, United States
GSK Investigational Site
Northport, Alabama, 35476, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Mesa, Arizona, 85201, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Scottsdale, Arizona, 85259, United States
GSK Investigational Site
Sun City, Arizona, 85351, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Sepuldeva, California, 91343, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20016, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Maitland, Florida, 32751, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33609, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Flossmoor, Illinois, 60422, United States
GSK Investigational Site
Springfield, Illinois, 62702, United States
GSK Investigational Site
Des Moines, Iowa, 50309-1426, United States
GSK Investigational Site
Wichita, Kansas, 67214, United States
GSK Investigational Site
Crestview Hills, Kentucky, 41017, United States
GSK Investigational Site
Lexington, Kentucky, 40536-0284, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Grand Rapids, Michigan, 49525, United States
GSK Investigational Site
Traverse City, Michigan, 49684, United States
GSK Investigational Site
Minneapolis, Minnesota, 55422, United States
GSK Investigational Site
Minneapolis, Minnesota, 55454, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Las Vegas, Nevada, 89103, United States
GSK Investigational Site
Edison, New Jersey, 08818, United States
GSK Investigational Site
West Orange, New Jersey, 07052, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Plainview, New York, 11803, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27514, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Columbus, Ohio, 43210-1250, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Cheswick, Pennsylvania, 15024, United States
GSK Investigational Site
Greensburg, Pennsylvania, 15601, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Galveston, Texas, 77555, United States
GSK Investigational Site
Houston, Texas, 77005, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Wichita Falls, Texas, 76301, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Richmond, Virginia, 23220, United States
GSK Investigational Site
Seattle, Washington, 98122-4358, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Capital Federal, Buenos Aires, 1181, Argentina
GSK Investigational Site
Curitiba, Paraná, 80069-900, Brazil
GSK Investigational Site
Campinas, São Paulo, 13083-970, Brazil
GSK Investigational Site
Santiago, Región Metro de Santiago, 7571831, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Singen, Baden-Wurttemberg, 78224, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89073, Germany
GSK Investigational Site
Alzenau in Unterfranken, Bavaria, 63755, Germany
GSK Investigational Site
Bamberg, Bavaria, 96047, Germany
GSK Investigational Site
Fürth, Bavaria, 90762, Germany
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Neuötting, Bavaria, 84524, Germany
GSK Investigational Site
Straubing, Bavaria, 94315, Germany
GSK Investigational Site
Unterhaching, Bavaria, 82008, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Bernau bei Berlin, Brandenburg, 16321, Germany
GSK Investigational Site
Ludwigsfelde, Brandenburg, 14974, Germany
GSK Investigational Site
Hamburg, Hamburg, 20249, Germany
GSK Investigational Site
Hamburg, Hamburg, 21029, Germany
GSK Investigational Site
Hamburg, Hamburg, 22083, Germany
GSK Investigational Site
Hamburg, Hamburg, 22523, Germany
GSK Investigational Site
Hamburg, Hamburg, 22527, Germany
GSK Investigational Site
Bad Homburg, Hesse, 61348, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60594, Germany
GSK Investigational Site
Giessen, Hesse, 35390, Germany
GSK Investigational Site
Bückeburg, Lower Saxony, 31675, Germany
GSK Investigational Site
Göttingen, Lower Saxony, 37075, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, 49074, Germany
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, 23966, Germany
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, 23970, Germany
GSK Investigational Site
Baesweiler, North Rhine-Westphalia, 52499, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44795, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44892, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50672, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50767, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45138, Germany
GSK Investigational Site
Hattingen, North Rhine-Westphalia, 45525, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149, Germany
GSK Investigational Site
Limburgerhof, Rhineland-Palatinate, 67117, Germany
GSK Investigational Site
Chemnitz, Saxony, 09111, Germany
GSK Investigational Site
Flöha, Saxony, 09557, Germany
GSK Investigational Site
Leipzig, Saxony, 04105, Germany
GSK Investigational Site
Radeberg, Saxony, 01465, Germany
GSK Investigational Site
Bernburg, Saxony-Anhalt, 06406, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06118, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39104, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39124, Germany
GSK Investigational Site
Naumburg, Saxony-Anhalt, 06618, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105, Germany
GSK Investigational Site
Berlin, State of Berlin, 10117, Germany
GSK Investigational Site
Berlin, State of Berlin, 10969, Germany
GSK Investigational Site
Berlin, State of Berlin, 13353, Germany
GSK Investigational Site
Jena, Thuringia, 07743, Germany
GSK Investigational Site
Jena-Lobeda, Thuringia, 07747, Germany
GSK Investigational Site
Hyderabad, Andhra Pradesh, 500482, India
GSK Investigational Site
Lucknow, 226003, India
GSK Investigational Site
New Delhi, India
GSK Investigational Site
San Germán, Puerto Rico, 00683, Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00918, Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00936, Puerto Rico
GSK Investigational Site
Moscow, 107076, Russia
GSK Investigational Site
Moscow, 111539, Russia
GSK Investigational Site
Moscow, 117049, Russia
GSK Investigational Site
Moscow, 119334, Russia
GSK Investigational Site
Moscow, 125412, Russia
GSK Investigational Site
Moscow, 127473, Russia
GSK Investigational Site
Saint Petersburg, 193019, Russia
GSK Investigational Site
Saint Petersburg, 197376, Russia
GSK Investigational Site
Yekaterinburg, 620102, Russia
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 138-736, South Korea
GSK Investigational Site
Seoul, 139-711, South Korea
GSK Investigational Site
Kharkiv, 61068, Ukraine
GSK Investigational Site
Kyiv, 02660, Ukraine
GSK Investigational Site
Lviv, 79021, Ukraine
Related Publications (2)
Naritoku DK, Warnock CR, Messenheimer JA, Borgohain R, Evers S, Guekht AB, Karlov VA, Lee BI, Pohl LR. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610-8. doi: 10.1212/01.wnl.0000277698.33743.8b.
PMID: 17938371BACKGROUNDvan Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.
PMID: 29363050DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2005
First Posted
June 7, 2005
Study Start
October 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
December 5, 2016
Record last verified: 2016-12
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.