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



Status:Completed
Conditions:Neurology, Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:13 - Any
Updated:10/14/2017
Start Date:October 2004
End Date:July 2007

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

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.


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 two
antiepileptic drugs for at least four weeks.

- Patient or parent/caregiver must be willing and able to maintain a written daily
seizure diary.

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.
We found this trial at
64
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GSK Investigational Site
Galveston, Texas 77555
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Anniston, Alabama 36207
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Asheville, North Carolina 28803
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Atlanta, Georgia 30341
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Atlanta, GA
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Augusta, Georgia 30909
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Augusta, GA
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Austell, Georgia 30106
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Birmingham, Alabama 35249
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Birmingham, AL
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Boston, Massachusetts 02115
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Capital Federal, Buenos Aires
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Capital Federal,
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Chapel Hill, North Carolina 27599
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Chesterfield, Missouri 63017
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Cheswick, Pennsylvania 15024
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Chicago, Illinois 60611
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Chicago, IL
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Columbus, Ohio 43219
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Crestview Hills, Kentucky 41017
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Dallas, Texas 75230
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Des Moines, Iowa 50314
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Detroit, Michigan 48202
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Edison, New Jersey
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Flossmoor, Illinois 60422
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Grand Rapids, Michigan 49546
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Greensburg, Pennsylvania 15601
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Greenville, North Carolina 27858
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Hollywood, Florida 33021
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Houston, Texas 77030
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Kansas City, Missouri 64128
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Las Vegas, Nevada 89102
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Lexington, Kentucky 40504
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Little Rock, Arkansas 72205
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Los Angeles, California 90025
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Louisville, Kentucky 40202
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Maitland, Florida 32751
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Mesa, Arizona 85206
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Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55404
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New York, New York 10032
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Newport Beach, California 92663
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Northport, Alabama 35476
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Ocala, Florida 34471
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Oklahoma City, Oklahoma 73112
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85012
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Plainview, New York 11803
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Raleigh, North Carolina 27614
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Richmond, Virginia 23298
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Salt Lake City, Utah 84132
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San Antonio, Texas 78258
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Santa Monica, California 90404
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Savannah, Georgia 31405
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Scottsdale, Arizona 85259
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Seattle, Washington 98109
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Sepuldeva, California 91343
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Springfield, Illinois 62702
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St. Louis, Missouri 63110
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Sun City, Arizona 85351
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Tallahassee, Florida 32308
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Tampa, Florida 33612
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Traverse City, Michigan 49684
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Tucson, Arizona 85724
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Tuscaloosa, Alabama 35401
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Washington, District of Columbia 20007
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West Orange, New Jersey 07052
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Wichita, Kansas 67207
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Wichita Falls, Texas 76310
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