This study will compare the effectiveness and safety of LAMICTAL extended-release with placebo in the treatment of primary generalized tonic-clonic seizures. LAMICTAL extended-release is investigational. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Condition	Treatment or Intervention	Phase
Tonic-Clonic Seizures Epilepsy	Drug: LAMICTAL (lamotrigine) 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 primary generalized tonic-clonic seizures for more than 24 weeks.
• Must experience at least 3 primary generalized tonic-clonic 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.
• Subjects receiving treatment with felbamate or currently following the ketogenic diet.
• Subjects who are pregnant, breastfeeding, or planning to become pregnant.

Alabama
      Tuscaloosa,  Alabama,  35406,  United States; Recruiting
      Anniston,  Alabama,  36207,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85013,  United States; Recruiting
Arkansas
      Little Rock,  Arkansas,  72205,  United States; Recruiting
Michigan
      Detroit,  Michigan,  48202,  United States; Recruiting
      Traverse City,  Michigan,  49684,  United States; Recruiting
Minnesota
      Minneapolis,  Minnesota,  55455,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  89121,  United States; Recruiting
New York
      Amherst,  New York,  14226,  United States; Recruiting
North Carolina
      Asheville,  North Carolina,  28806,  United States; Recruiting
Texas
      Wichita Falls,  Texas,  76301,  United States; Recruiting
Wisconsin
      Madison,  Wisconsin,  53715,  United States; Not yet recruiting

Study ID Numbers:  LAM100036
Record last reviewed:  February 2005
Last Updated:  February 28, 2005
Record first received:  February 28, 2005
ClinicalTrials.gov Identifier:  NCT00104416
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08