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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.
Time frame: 24 Weeks
Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics
Time frame: 24 Weeks
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GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Northport, Alabama, United States
GSK Investigational Site
Tuscaloosa, Alabama, United States
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Sun City, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
...and 138 more locations