Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

Last updated: December 2, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Epilepsy

Seizure Disorders

Treatment

N/A

Clinical Study ID

NCT00113165
LAM100034
  • Ages > 13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • 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 twoantiepileptic drugs for at least four weeks.

  • Patient or parent/caregiver must be willing and able to maintain a written dailyseizure diary.

Exclusion

Exclusion criteria:

  • 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.

Study Design

Total Participants: 244
Study Start date:
October 01, 2004
Estimated Completion Date:
July 31, 2007

Connect with a study center

  • GSK Investigational Site

    Capital Federal, Buenos Aires 1181
    Argentina

    Site Not Available

  • GSK Investigational Site

    Curitiba, Paraná 80069-900
    Brazil

    Site Not Available

  • GSK Investigational Site

    Campinas, São Paulo 13083-970
    Brazil

    Site Not Available

  • GSK Investigational Site

    Santiago, Región Metro De Santiago 7571831
    Chile

    Site Not Available

  • GSK Investigational Site

    Singen, Baden-Wuerttemberg 78224
    Germany

    Site Not Available

  • GSK Investigational Site

    Ulm, Baden-Wuerttemberg 89073
    Germany

    Site Not Available

  • GSK Investigational Site

    Alzenau, Bayern 63755
    Germany

    Site Not Available

  • GSK Investigational Site

    Bamberg, Bayern 96047
    Germany

    Site Not Available

  • GSK Investigational Site

    Fuerth, Bayern 90762
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, Bayern 80331
    Germany

    Site Not Available

  • GSK Investigational Site

    Neuoetting, Bayern 84524
    Germany

    Site Not Available

  • GSK Investigational Site

    Straubing, Bayern 94315
    Germany

    Site Not Available

  • GSK Investigational Site

    Unterhaching, Bayern 82008
    Germany

    Site Not Available

  • GSK Investigational Site

    Wuerzburg, Bayern 97070
    Germany

    Site Not Available

  • GSK Investigational Site

    Bernau, Brandenburg 16321
    Germany

    Site Not Available

  • GSK Investigational Site

    Ludwigsfelde, Brandenburg 14974
    Germany

    Site Not Available

  • GSK Investigational Site

    Bad Homburg, Hessen 61348
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankfurt, Hessen 60594
    Germany

    Site Not Available

  • GSK Investigational Site

    Giessen, Hessen 35390
    Germany

    Site Not Available

  • GSK Investigational Site

    Wismar, Mecklenburg-Vorpommern 23970
    Germany

    Site Not Available

  • GSK Investigational Site

    Bueckeburg, Niedersachsen 31675
    Germany

    Site Not Available

  • GSK Investigational Site

    Goettingen, Niedersachsen 37075
    Germany

    Site Not Available

  • GSK Investigational Site

    Osnabrueck, Niedersachsen 49074
    Germany

    Site Not Available

  • GSK Investigational Site

    Baesweiler, Nordrhein-Westfalen 52499
    Germany

    Site Not Available

  • GSK Investigational Site

    Bochum, Nordrhein-Westfalen 44892
    Germany

    Site Not Available

  • GSK Investigational Site

    Essen, Nordrhein-Westfalen 45138
    Germany

    Site Not Available

  • GSK Investigational Site

    Hattingen, Nordrhein-Westfalen 45525
    Germany

    Site Not Available

  • GSK Investigational Site

    Koeln, Nordrhein-Westfalen 50767
    Germany

    Site Not Available

  • GSK Investigational Site

    Moenchengladbach, Nordrhein-Westfalen 41061
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • GSK Investigational Site

    Limburgerhof, Rheinland-Pfalz 67117
    Germany

    Site Not Available

  • GSK Investigational Site

    Chemnitz, Sachsen 09111
    Germany

    Site Not Available

  • GSK Investigational Site

    Floeha, Sachsen 09557
    Germany

    Site Not Available

  • GSK Investigational Site

    Leipzig, Sachsen 04105
    Germany

    Site Not Available

  • GSK Investigational Site

    Radeberg, Sachsen 01465
    Germany

    Site Not Available

  • GSK Investigational Site

    Bernburg, Sachsen-Anhalt 06406
    Germany

    Site Not Available

  • GSK Investigational Site

    Halle, Sachsen-Anhalt 06118
    Germany

    Site Not Available

  • GSK Investigational Site

    Magdeburg, Sachsen-Anhalt 39104
    Germany

    Site Not Available

  • GSK Investigational Site

    Naumburg, Sachsen-Anhalt 06618
    Germany

    Site Not Available

  • GSK Investigational Site

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • GSK Investigational Site

    Jena, Thueringen 07743
    Germany

    Site Not Available

  • GSK Investigational Site

    Jena-Lobeda, Thueringen 07747
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 10969
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 22083
    Germany

    Site Not Available

  • GSK Investigational Site

    Hyderabad, Andhra Pradesh, 500482
    India

    Site Not Available

  • GSK Investigational Site

    Lucknow, 226003
    India

    Site Not Available

  • GSK Investigational Site

    New Delhi,
    India

    Site Not Available

  • GSK Investigational Site

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    San German, 00683
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Moscow, 117049
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St.-Petersburg, 197376
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • GSK Investigational Site

    Kyiv, 02660
    Ukraine

    Site Not Available

  • GSK Investigational Site

    Lviv, 79021
    Ukraine

    Site Not Available

  • GSK Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35294-0021
    United States

    Site Not Available

  • GSK Investigational Site

    Northport, Alabama 35476
    United States

    Site Not Available

  • GSK Investigational Site

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • GSK Investigational Site

    Mesa, Arizona 85201
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • GSK Investigational Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85712
    United States

    Site Not Available

  • GSK Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • GSK Investigational Site

    Sepuldeva, California 91343
    United States

    Site Not Available

  • GSK Investigational Site

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • GSK Investigational Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • GSK Investigational Site

    Maitland, Florida 32751
    United States

    Site Not Available

  • GSK Investigational Site

    Ocala, Florida 34471
    United States

    Site Not Available

  • GSK Investigational Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33609
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • GSK Investigational Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • GSK Investigational Site

    Austell, Georgia 30106
    United States

    Site Not Available

  • GSK Investigational Site

    Savannah, Georgia 31405
    United States

    Site Not Available

  • GSK Investigational Site

    Chicago, Illinois 60612
    United States

    Site Not Available

  • GSK Investigational Site

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • GSK Investigational Site

    Springfield, Illinois 62702
    United States

    Site Not Available

  • GSK Investigational Site

    Des Moines, Iowa 50309-1426
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67214
    United States

    Site Not Available

  • GSK Investigational Site

    Crestview Hills, Kentucky 41017
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • GSK Investigational Site

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • GSK Investigational Site

    Traverse City, Michigan 49684
    United States

    Site Not Available

  • GSK Investigational Site

    Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • GSK Investigational Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • GSK Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • GSK Investigational Site

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • GSK Investigational Site

    Las Vegas, Nevada 89103
    United States

    Site Not Available

  • GSK Investigational Site

    Edison, New Jersey 08818
    United States

    Site Not Available

  • GSK Investigational Site

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10016
    United States

    Site Not Available

  • GSK Investigational Site

    Plainview, New York 11803
    United States

    Site Not Available

  • GSK Investigational Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • GSK Investigational Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Ohio 43210-1250
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GSK Investigational Site

    Cheswick, Pennsylvania 15024
    United States

    Site Not Available

  • GSK Investigational Site

    Greensburg, Pennsylvania 15601
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • GSK Investigational Site

    Galveston, Texas 77555
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77005
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78258
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita Falls, Texas 76301
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    Richmond, Virginia 23220
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98122-4358
    United States

    Site Not Available

  • GSK Investigational Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.