Oxcarbazepine - Double-blind, randomized, placebo-control, monotherapy trial for partial seizures

Objective: To evaluate the efficacy and safety of oxcarbazepine in a placeb o-control trial. Methods: A multicenter, double-blind, randomized, placebo- control, two-arm parallel group, monotherapy design was used to compare oxc arbazepine administered 1,200 mg twice daily to placebo in hospitalized pat ients with refractory partial seizures, including simple and complex partia l seizures and partial seizures evolving to secondarily generalized seizure s. Patients exited the trial after completing the 10-day double-blind treat ment phase or after experiencing four partial seizures, two new-onset secon darily generalized seizures, serial seizures, or status epilepticus, whiche ver came first. Results: Analysis of the primary efficacy variable-time to meeting one of the exit criteria-showed a statistically significant effect in favor of oxcarbazepine (p = 0.0001). The secondary efficacy variables-pe rcentage of patients who met one of the exit criteria (p = 0.0001) and tota l partial seizure frequency per 9 days during the double-blind treatment (p = 0.0001)-were also statistically significant in favor of oxcarbazepine. C onclusion: These results demonstrate that oxcarbazepine given as monotherap y is effective and safe for the treatment of partial seizures in this parad igm.