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From the Epilepsy Research Center (S.F.B.), Department of Medicine, University of Melbourne, Austin Health, Australia; UAB Epilepsy Center (R.C.K.), Department of Neurology, University of Alabama at Birmingham School of Medicine; Neurological Clinic of Texas (R.F.L.), Dallas; UCB Inc. (J.S.), Atlanta, GA; and UCB Pharma SA (U.F.), Braine-l’Alleud, Belgium.
Address correspondence and reprint request to Dr Berkovic, Epilepsy Research Center, Heidelberg Repatriation Hospital, Banksia Street, West Heidelberg, Victoria, Australia 3081 s.berkovic{at}unimelb.edu.au
Objective: To assess the efficacy and tolerability of adjunctive levetiracetam in patients with uncontrolled generalized tonic-clonic (GTC) seizures associated with idiopathic generalized epilepsies (IGE).
Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled adults and children (4 to 65 years) with IGE experiencing 
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.
Results: 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 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.
Conclusion: Adjunctive levetiracetam is an effective and well-tolerated antiepileptic drug for treating generalized tonic-clonic seizures in patients with idiopathic generalized epilepsies.
Editorial, see page 1734
e-Pub ahead of print on July 11, 2007, at www.neurology.org
*Members of the N01057 Study Group are listed in the appendix.
Disclosure: This study was sponsored by UCB Pharma SA, who were involved in the design and conduct of the study; collection, management, and analysis of the data; and preparation and review of the manuscript. Dr. S.F. Berkovic has received grants from UCB Pharma (exceeding $10,000), Janssen-Cilag, Pfizer, and Novartis. Dr. R.C. Knowlton has received grants from GlaxoSmithKline, Novartis, Ortho McNeil, and UCB Pharma. Dr. R.F. Leroy has received grants from UCB Pharma (exceeding $10,000), Valeant Pharmaceutics, GlaxoSmithKline, Johnson and Johnson, Schwartz Pharma, and Eisai. J. Schiemann is an employee of UCB Inc., Atlanta, GA; U. Falter is an employee of UCB Pharma SA, Braine-l’Alleud, Belgium.
Received February 14, 2007. Accepted in final form April 19, 2007.
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  S. Noachtar, E. Andermann, P. Meyvisch, F. Andermann, W. B. Gough, J. Schiemann-Delgado, and For the N166 Levetiracetam Study Group Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures Neurology, February 19, 2008; 70(8): 607 - 616. [Abstract] [Full Text] [PDF]
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 Levetiracetam for Idiopathic Generalized Epilepsy Journal Watch (General), November 6, 2007; 2007(1106): 2 - 2. [Full Text]
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