Study: Adding Vimpat significantly reduces partial-onset seizures in adults wit...(he Study Researchers in Europe and ...),Health

Researchers in Europe and Australia enrolled 485 patients, aged 16 to 70 years, who had uncontrolled partial-onset seizures, with or without secondary generalizations, for at least two years despite prior therapy with at least two AEDs. The objective of this trial was to evaluate the efficacy and safety of lacosamide doses of 200 mg/day and 400 mg/day. In the study, Vimpat was evaluated in combination with a broad range of both first and second generation AEDs. The five concomitant AEDs taken most frequently by patients in the study were carbamazepine, valproate, lamotrigine, topiramate, and levetiracetam. The mean number of years since diagnosis of epilepsy was 22.3 ( 12.56 years).

During the first eight weeks of the trial, researchers measured baseline seizure frequency rates. Patients were then randomized to receive Vimpat 200 mg/day, Vimpat 400 mg/day or placebo (along with prior AEDs), followed by a four-week forced titration period. Patients were started on either placebo or Vimpat 100 mg/day. Patients in the Vimpat groups were then given increasing doses, in increments of 100 mg/day each week, until reaching the maintenance doses of either 200 mg/day or 400 mg/day. The Vimpat 200 mg/day group received placebo for first 2 weeks to allow all patients to reach the target maintenance dose simultaneously. Patients remained on their final dosing schedule throughout the subsequent 12-week maintenance phase. The efficacy assessment was conducted on an intent-to-treat (ITT) basis that included all randomized patients who had received at least one dose of trial medication and had at least one post-baseline efficacy assessment.

Patients completing the maintenance period were eligible to enter an open-label lacosamide extension trial.

'/>"/>