This study is being conducted to compare the effectiveness and safety of LAMICTAL 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.

Condition	Treatment or Intervention	Phase
Epilepsy	Drug: LAMICTAL extended-release	Phase III

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Must have a 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.
• Receiving treatment with felbamate or currently following the ketogenic diet.
• Pregnant, breastfeeding, or planning to become pregnant.

Please refer to this study by ClinicalTrials.gov identifier  NCT00113165

Alabama
      Birmingham,  Alabama,  35294,  United States; Not yet recruiting
      Tuscaloosa,  Alabama,  35406,  United States; Not yet recruiting
      Northport,  Alabama,  35476,  United States; Recruiting
      Anniston,  Alabama,  36207,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85006,  United States; Recruiting
      Scottsdale,  Arizona,  85259,  United States; Not yet recruiting
      Tucson,  Arizona,  85712,  United States; Recruiting
Arkansas
      Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Los Angeles,  California,  90033,  United States; Recruiting
      West Los Angeles,  California,  90073,  United States; Not yet recruiting
      Santa Monica,  California,  90404,  United States; Recruiting
      North Hills,  California,  91343,  United States; Not yet recruiting
      Newport Beach,  California,  92660,  United States; Recruiting
District of Columbia
      Washington,  District of Columbia,  20037,  United States; Recruiting
Florida
      Tallahassee,  Florida,  32308,  United States; Recruiting
      Maitland,  Florida,  32751,  United States; Recruiting
      Hollywood,  Florida,  33021,  United States; Recruiting
      Miami,  Florida,  33136,  United States; Not yet recruiting
      Tampa,  Florida,  33609,  United States; Recruiting
      Ocala,  Florida,  34471,  United States; Recruiting
Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
      Atlanta,  Georgia,  30342,  United States; Recruiting
      Augusta,  Georgia,  30912,  United States; Not yet recruiting
      Savannah,  Georgia,  31405,  United States; Recruiting
Illinois
      Flossmoor,  Illinois,  60422,  United States; Recruiting
      Chicago,  Illinois,  60612,  United States; Not yet recruiting
      Springfield,  Illinois,  62702,  United States; Recruiting
Iowa
      Des Moines,  Iowa,  50309,  United States; Recruiting
      Iowa City,  Iowa,  52242,  United States; Not yet recruiting
Kansas
      Wichita Falls,  Kansas,  67214,  United States; Recruiting
Kentucky
      Louisville,  Kentucky,  40202,  United States; Not yet recruiting
      Lexington,  Kentucky,  40536,  United States; Not yet recruiting
      Crestview Hills,  Kentucky,  41017,  United States; Recruiting
Louisiana
      Lafayette,  Louisiana,  70503,  United States; Recruiting
Massachusetts
      Boston,  Massachusetts,  02118,  United States; Recruiting
      Boston,  Massachusetts,  02215,  United States; Not yet recruiting
Michigan
      Detroit,  Michigan,  48202,  United States; Recruiting
      Grand Rapids,  Michigan,  49525,  United States; Recruiting
      Traverse City,  Michigan,  49684,  United States; Recruiting
Minnesota
      Golden Valley,  Minnesota,  55422,  United States; Recruiting
      Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      Chesterfield,  Missouri,  63017,  United States; Recruiting
      St. Louis,  Missouri,  63110,  United States; Not yet recruiting
Nevada
      Las Vegas,  Nevada,  89103,  United States; Recruiting
      Las Vegas,  Nevada,  89121,  United States; Not yet recruiting
New Jersey
      West Orange,  New Jersey,  07052,  United States; Recruiting
      Edison,  New Jersey,  08818,  United States; Not yet recruiting
New York
      New York,  New York,  10016,  United States; Recruiting
      Plainview,  New York,  11803,  United States; Recruiting
North Carolina
      Chapel Hill,  North Carolina,  27599,  United States; Not yet recruiting
      Raleigh,  North Carolina,  27607,  United States; Recruiting
      Asheville,  North Carolina,  28806,  United States; Recruiting
Ohio
      Columbus,  Ohio,  43210,  United States; Recruiting
      Akron,  Ohio,  44308,  United States; Not yet recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  73104,  United States; Not yet recruiting
      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  15212,  United States; Not yet recruiting
      Greensburg,  Pennsylvania,  15601,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Texas
      Dallas,  Texas,  75230,  United States; Recruiting
      Detroit,  Texas,  75390,  United States; Not yet recruiting
      Witchita Falls,  Texas,  76301,  United States; Recruiting
      Houston,  Texas,  77054,  United States; Recruiting
      Galveston,  Texas,  77555,  United States; Not yet recruiting
Virginia
      Richmond,  Virginia,  23298,  United States; Recruiting
Washington
      Seattle,  Washington,  98122,  United States; Recruiting
Wisconsin
      Milwaukee,  Wisconsin,  53215,  United States; Not yet recruiting

Study ID Numbers:  LAM100034
Record last reviewed:  June 2005
Last Updated:  June 6, 2005
Record first received:  June 6, 2005
ClinicalTrials.gov Identifier:  NCT00113165
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-06-07