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| | | ![]() ENS: Partial-Onset Seizures Improve With Levetiracetam By Jill Stein Special to DG News
PARIS, FRANCE -- April 24, 2001 -- Adjunctive therapy with levetiracetam (LEV) is safe and effective for controlling partial-onset seizures in epileptic patients, according to the results of a multicenter US trial. The findings were presented at the 11th Meeting of the European Neurological Society by Dr. James Cereghino, with Oregon Health Sciences University in Portland. The 294 subjects ranged from 16 to 70 years of age and had uncontrolled partial seizures (with or without secondary generalization) for at least two years. In order to be eligible for enrollment, patients also had to have at least 12 partial seizures within in the prior 12 weeks and had to have received at least two marketed anti-epileptic drugs simultaneously or consecutively, and had to be stabilized on one or two appropriate anti-epileptic drugs at usual plasma concentrations. A 12-week baseline period was followed by random assignment to adjunctive therapy with placebo (n=95), LEV 1,000 mg/d (n=98), or LEV 3,000 mg/d (n=101). Upward titration over four weeks was followed by 14 weeks of fixed-dose treatment, and concluded with an eight-week medication withdrawal period or entry into a follow-up study. Both LEV doses significantly decreased partial seizure frequency compared to placebo, Dr. Cereghino reported on behalf of the LEV N132 Study Group. Both doses also achieved significantly higher responder rates (greater than or equal to 50 percent and greater than or equal to 75 percent reductions in partial seizure frequency) than placebo. Significant clinical improvement became apparent within two weeks of the start of treatment. Eleven (5.5 percent) of 199 LEV patients were seizure- free during the 14-week evaluation period compared with none of 95 placebo patients. Seizure reduction was notable for all seizure subtypes with significant decreases in complex partial seizures (type 1B) and secondarily generalized seizures (type 1C). Side effects were mainly central nervous system-related; somnolence and dizziness were the most frequent but were mild to moderate and rarely led to withdrawal.
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