Pediatric Epilepsy Study in Subjects 1-24 Months



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:10/14/2017
Start Date:September 2000
End Date:June 2006

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with
partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age
who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will
be added to the subject's current epilepsy medications.


Inclusion criteria:

- Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for
LAMICTAL naive subjects as follows:

- A confident diagnosis of epilepsy.

- 4 or more partial seizures per month.

- current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

- Has seizures not related to epilepsy.

- Has a surgically implanted and functioning vagal nerve stimulator.

- Has previously been treated with lamotrigine.

- Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the
ketogenic diet.

- Use of experimental medication within 30 days of enrollment.
We found this trial at
40
sites
GSK Investigational Site
Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Akron, Ohio 44313
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Akron, OH
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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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Buffalo, New York 14263
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Buffalo, NY
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GSK Investigational Site
Capital Federal, Buenos Aires
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Capital Federal,
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charlottesville, Virginia 22903
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Charlottesville, VA
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GSK Investigational Site
Cherry Hill, New Jersey 08003
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Cherry Hill, NJ
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GSK Investigational Site
Cleveland, Ohio 44195
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Cleveland, OH
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GSK Investigational Site
Columbia, Missouri 65201
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Columbia, MO
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GSK Investigational Site
Columbus, Ohio 43219
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Columbus, OH
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Dallas, Texas 75230
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Dallas, TX
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GSK Investigational Site
Denver, Colorado 80206
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Denver, CO
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GSK Investigational Site
Fort Worth, Texas 76104
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Fort Worth, TX
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GSK Investigational Site
Houston, Texas 77030
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Houston, TX
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GSK Investigational Site
Jacksonville, Florida 32207
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Jacksonville, FL
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GSK Investigational Site
Jonesboro, Arkansas 72401
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Jonesboro, AR
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GSK Investigational Site
Kansas City, Missouri 64128
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Kansas City, MO
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GSK Investigational Site
Lexington, Kentucky 40504
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Lexington, KY
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Little Rock, Arkansas 72205
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Little Rock, AR
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Los Angeles, California 90025
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Los Angeles, CA
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GSK Investigational Site
Miami, Florida 33136
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Miami, FL
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Mineola, New York 11501
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Mineola, NY
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Mobile, Alabama 36617
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Mobile, AL
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Morristown, Tennessee 37813
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Morristown, TN
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Nashville, Tennessee 37203
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Nashville, TN
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Norfolk, Virginia 23502
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Norfolk, VA
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GSK Investigational Site
Orlando, Florida 32806
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Orlando, FL
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GSK Investigational Site
Portland, Oregon 97227
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Portland, OR
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GSK Investigational Site
Raleigh, North Carolina 27614
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Raleigh, NC
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Richmond, Virginia 23298
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Richmond, VA
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GSK Investigational Site
Salt Lake City, Utah 84132
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Salt Lake City, UT
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St. Paul, Minnesota 55102
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St. Paul, MN
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GSK Investigational Site
Stanford, California 94305
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Stanford, CA
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Syracuse, New York 13210
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Syracuse, NY
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Tallahassee, Florida 32308
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Tallahassee, FL
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Tampa, Florida 33612
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Tampa, FL
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Tucson, Arizona 85724
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Washington, District of Columbia 20007
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Washington,
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