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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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
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Akron, Ohio 44313
2037
mi
from 98109
Akron, OH
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Atlanta, Georgia 30341
2176
mi
from 98109
Atlanta, GA
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Augusta, Georgia 30909
2296
mi
from 98109
Augusta, GA
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Buffalo, New York 14263
2110
mi
from 98109
Buffalo, NY
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Capital Federal, Buenos Aires
6918
mi
from 98109
Capital Federal,
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Chapel Hill, North Carolina 27599
2337
mi
from 98109
Chapel Hill, NC
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Charlottesville, Virginia 22903
2285
mi
from 98109
Charlottesville, VA
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Cherry Hill, New Jersey 08003
2380
mi
from 98109
Cherry Hill, NJ
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Cleveland, Ohio 44195
2024
mi
from 98109
Cleveland, OH
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Columbia, Missouri 65201
1611
mi
from 98109
Columbia, MO
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Columbus, Ohio 43219
2009
mi
from 98109
Columbus, OH
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Dallas, Texas 75230
1675
mi
from 98109
Dallas, TX
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Denver, Colorado 80206
1022
mi
from 98109
Denver, CO
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Fort Worth, Texas 76104
1662
mi
from 98109
Fort Worth, TX
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Jacksonville, Florida 32207
2454
mi
from 98109
Jacksonville, FL
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Jonesboro, Arkansas 72401
1806
mi
from 98109
Jonesboro, AR
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Kansas City, Missouri 64128
1506
mi
from 98109
Kansas City, MO
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Lexington, Kentucky 40504
2003
mi
from 98109
Lexington, KY
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Little Rock, Arkansas 72205
1779
mi
from 98109
Little Rock, AR
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Los Angeles, California 90025
960
mi
from 98109
Los Angeles, CA
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Mineola, New York 11501
2417
mi
from 98109
Mineola, NY
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Mobile, Alabama 36617
2148
mi
from 98109
Mobile, AL
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Morristown, Tennessee 37813
2129
mi
from 98109
Morristown, TN
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Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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Norfolk, Virginia 23502
2434
mi
from 98109
Norfolk, VA
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Orlando, Florida 32806
2549
mi
from 98109
Orlando, FL
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Pittsburgh, Pennsylvania 15213
2134
mi
from 98109
Pittsburgh, PA
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Portland, Oregon 97227
145
mi
from 98109
Portland, OR
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Raleigh, North Carolina 27614
2356
mi
from 98109
Raleigh, NC
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Richmond, Virginia 23298
2352
mi
from 98109
Richmond, VA
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Salt Lake City, Utah 84132
702
mi
from 98109
Salt Lake City, UT
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St. Paul, Minnesota 55102
1399
mi
from 98109
St. Paul, MN
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Stanford, California 94305
705
mi
from 98109
Stanford, CA
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Syracuse, New York 13210
2233
mi
from 98109
Syracuse, NY
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Tallahassee, Florida 32308
2330
mi
from 98109
Tallahassee, FL
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Tampa, Florida 33612
2522
mi
from 98109
Tampa, FL
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Tucson, Arizona 85724
1219
mi
from 98109
Tucson, AZ
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Washington, District of Columbia 20007
2322
mi
from 98109
Washington,
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