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Title: Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy.
Austin Authors: Berkovic, Samuel F ;Knowlton, R C;Leroy, R F;Schiemann, J;Falter, U
Institutional Author: Levetiracetam N01057 Study Group
Affiliation: Epilepsy Research Center, Heidelberg Repatriation Hospital, Banksia Street, West Heidelberg, Victoria, Australia
Issue Date: 11-Jul-2007
Publication information: Neurology 2007; 69(18): 1751-60
Abstract: To assess the efficacy and tolerability of adjunctive levetiracetam in patients with uncontrolled generalized tonic-clonic (GTC) seizures associated with idiopathic generalized epilepsies (IGE).This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled adults and children (4 to 65 years) with IGE experiencing >or=3 GTC seizures during the 8-week baseline period (4-week retrospective and 4-week prospective), despite receiving stable doses of one or two antiepileptic drugs (AEDs). Patients were randomized to levetiracetam (target dose 3,000 mg/day for adults; 60 mg/kg/day for children) or placebo and a 4-week titration period was followed by a 20-week evaluation period.Of 229 patients screened, 164 were randomized (levetiracetam, n = 80; placebo, n = 84). Levetiracetam produced a greater mean reduction in GTC seizure frequency per week over the treatment period (56.5%) than placebo (28.2%; p = 0.004). The percentage of patients who had >or=50% reduction of GTC seizure frequency per week (responders) during the treatment period was 72.2% for levetiracetam and 45.2% for placebo (p < 0.001; OR 3.28; 95% CI 1.68 to 6.38). During the first 2-week treatment 64.6% of patients on levetiracetam and 45.2% on placebo (p = 0.018) were classified as responders. During the evaluation period the percent of patients free of GTC seizures (34.2% vs 10.7%; p < 0.001) and all seizure types (24.1% vs 8.3%; p = 0.009) was greater for levetiracetam than placebo. Levetiracetam was well tolerated with 1.3% of patients discontinuing therapy due to adverse events vs 4.8% on placebo.Adjunctive levetiracetam is an effective and well-tolerated antiepileptic drug for treating generalized tonic-clonic seizures in patients with idiopathic generalized epilepsies.
Gov't Doc #: 17625106
DOI: 10.1212/01.wnl.0000268699.34614.d3
Type: Journal Article
Subjects: Adolescent
Anticonvulsants.therapeutic use
Child, Preschool
Double-Blind Method
Epilepsy, Generalized.drug therapy
Middle Aged
Piracetam.analogs & derivatives.therapeutic use
Quality of Life
Research Design
Treatment Outcome
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