Evaluation of Lacosamide Efficacy in Subjects with Partial-Onset Seizures Across the Dose Range Used in Phase II/III Clinical Trials
In the individual trials and pooled analysis in this evaluation, Vimpat(R) significantly reduced seizures at all doses studied (200, 400, and 600 mg/day). The individual trials demonstrated that:
-- The 400 and 600 mg/day Vimpat(R) dose groups were significantly different from placebo for both primary efficacy endpoints in all trials using these doses.
-- The 200 mg/day Vimpat(R) dose group demonstrated significant seizure reduction versus placebo in the phase III trial (SP 755), but not in the phase II trial (SP667). To further evaluate the effectiveness of the 200 mg/day dose, a meta-analysis was conducted; results showed a significant difference compared to placebo for both primary endpoints.
The pooled results among patients entering the maintenance period demonstrated statistically significant reductions in seizure frequency at all doses studied compared to placebo:
-- Seizure frequency was significantly reduced by 33.5 percent for the 200 mg/day group (p <.05 ) and by more than 40 percent for the 400 and 600 mg/day groups (41.4 percent and 48.8 percent, respectively), compared with 19.2 percent for placebo (p<.0001).
-- Responder rates (patients with 50 percent or greater reduction in seizure frequency) were 34.8 percent for 200 mg/day (p <.05), 44.3 percent for 400 mg/day, and 48.6 percent for 600 mg/day, and 23.1 percent for placebo (p<.0001).
-- Additionally, there was a dose-responsive trend for improved seizure
freedom rates among subjects who completed the maintenance period (2.7
percent, 3.3 percent, and 4.8 percent with increasing Vimpat(R) doses vs. 0.
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