( nal formulationdemonstrated fewer dail...)New Data Shows Once a Day Lamictal XR is Effective in Treating,Patients with Partial Seizures,Health

ABOUT THE ARMOR STUDY

In the ARMOR study, patients naive to Lamictal, thirteen years of age or older with uncontrolled partial seizures, taking a stable regimen of 1 or 2 AEDs were enrolled in an 8 week baseline phase. Patients having 8 or more partial seizures were randomized to receive either once daily Lamictal XR or placebo. The treatment period consisted of escalation (7 weeks) and maintenance phases (12 weeks) with dosing based on background AEDs. The primary endpoint was percentage change from baseline in weekly partial seizures during the entire treatment phase.

Of 326 patients enrolled, 236 were randomized and included in the intent- to-treat population (116 Lamictal XR, 120 placebo). The median percent decrease from baseline in all partial seizures was 46 percent compared to 24 percent for placebo during the entire treatment phase, 28 percent compared to 16 percent during the escalation phase of treatment and 58 percent compared to 27 percent during the maintenance phase of treatment.

Time to greater than or equal to 50 percent reduction in seizure frequency was analyzed using a two sided log-rank statistic. In patients taking Lamictal XR, 42 percent achieved greater than or equal to 50 percent reduction in seizure frequency at the end of the treatment period. The time to achieve and maintain greater than or equal to 50 percent reduction in seizure frequency with Lamictal XR was reached at day 18. During the 12-week maintenance period, the percent of patients with 100 percent decrease from baseline partial seizures were 19 percent and 5 percent (Lamictal XR vs. placebo).

The most common (>5 percent) drug-related adverse events for Lamictal XR and placebo, respectively, were dizziness, 18 vs. 5 percent, headache, 17 vs. 15 percent, somnolence, 7 vs. 4 percent, nausea, 7 vs. 2 percent, and diarrhea, 7 vs. 4
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