Phase 3 Results for Lacosamide Monotherapy in Partial-Onset Seizures
UCB announced positive results for a Phase 3 study designed to evaluate the efficacy and safety of conversion to lacosamide monotherapy in adult patients with partial-onset seizures with or without secondary generalization compared with a historical control.
The study was an international, historical-controlled, multicenter, double-blind, randomized trial evaluating lacosamide 400mg/day for conversion to monotherapy in 427 patients, aged 16–70 years with partial-onset seizures taking 1–2 other anti-epileptic drugs (AEDs). A lacosamide 300 mg/day arm was added to blind the treatment group and to ensure a study design consistent with the historical control studies on which the conversion to lacosamide monotherapy study was based. The primary efficacy endpoint of the study was the percentage of patients who met at least one of the defined exit criteria by Day 112 relative to the start of withdrawal of background antiepileptic drugs and compared with the historical control.
The study met its primary endpoint demonstrating that the exit rate for patients on lacosamide 400mg/day was significantly lower than the historical control.
Vimpat (lacosamide) is approved as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy ages >17 years. Vimpat is available as tablets, IV injection, and oral solution.
For more information call (800) 234-5535 or visit www.ucbpharma.com.