Abstracts

RATIONALE: Intravenous formulations of antiepileptic drugs (AEDs) are needed in clinical situations where an oral formulation cannot be administered. This study evaluated the efficacy and safety of the monohydroxy derivative (MHD) of oxcarbazepine administered i.v. as adjunctive therapy in patients with refractory partial epilepsy undergoing epilepsy surgery evaluation. METHODS: This was a multicenter, double-blind, randomized, placebo-control, parallel-group study. Patients were randomized to receive either MHD i.v. (2400mg/day) or placebo i.v. The study consisted of a 48-hour baseline and a 7-day double-blind treatment phase. Patients with 2-10 partial seizures during baseline, receiving no more than one AED were randomized. Patients completed the trial either after 7 days of treatment or after meeting one of the exit criteria (i.e. 3 partial seizures, 1 new-onset secondarily generalized seizure, serial/prolonged seizures or status epilepticus). The percentage of patients meeting an exit criteria was the primary efficacy variable. The Cochran-Mantel-Haenszel (CMH) test adjusted for center effects was used to compare treatment groups. RESULTS: Of 107 randomized patients, 85 (79.4%) patients completed the trial, 34/52 MHD-patients and 51/55 placebo-treated patients. 22 (20.6%) patients prematurely discontinued. Out of patients who completed the trial, 18 (52.9%) MHD-treated and 46 (90.2%) placebo-treated patients met one of the exit criteria during double-blind treatment. This result was significant in favor of MHD (p=0.0001). The principal reason for premature discontinuation was due to adverse events in both treatment groups, 13 (25.0%) in MHD, 4 (7.3%) in placebo. The most frequent adverse events were nausea and dizziness. CONCLUSIONS: MHD i.v.is an effective and safe short-term treatment for seizure control in patients with medically refractory partial epilepsy.