"Double-blind randomized trial to assess efficacy and tolerability of once-daily extended-release levetiracetam (LEV XR) tablets (2 x 500 mg) as add-on therapy in patients (12 70 years old) with partial-onset seizures (POS) refractory to one to three antiepileptic drugs. After an 8-week prospective baseline-period, eligible patients were randomized (1: 1) to once-daily LEV XR 1,000 mg/day or placebo for 12 weeks," researchers in Tampere, Finland report (see also Epilepsy).

"Evaluations included changes from baseline in POS-frequency/week, responders (>= 50% reduction in POS-frequency/week), seizure-freedom, adverse events, laboratory tests, physical and neurologic examinations, vital signs, body-weight, and 12-lead electrocardiogram. Of 188 patients screened, 158 were randomized (intention-to-treat population): LEV XR (n = 79) or placebo (n = 79). Seventy-one (89.9%) LEV XR and 72 (91.1%) placebo patients completed the trial. Median POS-frequency/week reduction was 46.1% on LEV XR and 33.4% on placebo. Estimated reduction with LEV XR over placebo was 14.4% (p = 0.038). Thirty-four (43%) LEV XR and 23 (29.1%) placebo patients experienced >= 50% reduction in POS-frequency/week. Eight (10.1%) patients receiving LEV XR and one (1.3%) receiving placebo were free of POS during the 12-week treatment period. Forty-one (53.2%) LEV XR and 43 (54.4%) placebo patients reported 1 adverse event. Adverse events reported with an incidence >5% and seen more often with LEV XR than with placebo were somnolence, influenza, irritability, nasopharyngitis, dizziness, and nausea. Once-daily LEV XR 1,000 mg was effective and well-tolerated as adjunct therapy in patients with POS. Ten percent of patients randomized to LEV XR experienced freedom from POS," wrote J. Peltola and colleagues, Tampere University.

The researchers concluded: "These results support the clinical value of this new LEV XR formulation.."

Peltola and colleagues published their study in Epilepsia (Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: A double-blind, randomized, placebo-controlled trial. Epilepsia, 2009;50(3):406-414).

For additional information, contact J. Peltola, Tampere University Hospital, Dept. of Neurology, POB 2000, 33521 TRE, Tampere, Finland.

Publisher contact information for the journal Epilepsia is: Wiley-Blackwell Publishing, Inc., Commerce Place, 350 Main St., Malden 02148, MA, USA.

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