New Data Published in Neurology Show Once-Daily Lamictal XR Significantly Reduced Partial Seizures in Patients wit...(was an international multi-center random...),Health

Date:10/15/2007

was an international, multi-center, randomized, double-blind, placebo-controlled trial of patients naive to Lamictal, 13 years of age or older who were experiencing eight or more partial seizures during the eight- week baseline period despite taking a stable regimen of one or two antiepileptic drugs (AEDs). Two hundred and thirty-nine patients were randomized to receive either once-daily Lamictal XR or placebo (118 Lamictal XR, 121 placebo). The 19-week treatment period of the study consisted of a seven-week Escalation Phase and a 12-week Maintenance Phase.

The study's primary endpoint was median percent reduction from baseline in partial seizure frequency. Study results showed that Lamictal XR significantly reduced partial seizures by 46.1 percent, compared to 24.2 percent with placebo over the entire 19-week treatment period (P=0.0004). The study also showed significant overall reduction in seizure frequency with Lamictal XR in both the Escalation and Maintenance treatment phases of the study (P=0.028 and P=0.0001, respectively).

The percentage of patients who achieved a .50 percent reduction in partial seizure frequency during the 19-week treatment phase of the study was also significantly higher in the Lamictal XR group compared to placebo (42.2 percent versus 24.2 percent). In addition, the time to achieve and maintain a .50 percent reduction in partial onset seizure frequency was significantly shorter for the group treated with Lamictal XR compared to placebo. Statistical significance was evident at Day 18 and was maintained throughout the 19-week treatment phase of the study.

The median percent reduction from baseline in weekly frequency of secondarily generalized seizures was also significantly higher in patients receiving Lamictal XR compared to placebo (55.2 percent vs. 3.2 percent). Similar results were observed for the escalation and maintenance phases of the study.

The percentage of patients with at least one adverse event during
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