Open AccessLevetiracetam Efficacy in Idiopathic Generalized Epilepsy: Long Suspected and Now Confirmed in Randomized Clinical Trials
Author(s) -
AbouKhalil Bassel W.
Publication year - 2007
Publication title -
epilepsy currents
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.415
H-Index - 22
eISSN - 1535-7511
pISSN - 1535-7597
DOI - 10.1111/j.1535-7511.2007.00221.x
Subject(s) - levetiracetam , medicine , placebo , tolerability , randomized controlled trial , epilepsy , pediatrics , adjunctive treatment , clinical trial , anesthesia , idiopathic generalized epilepsy , adverse effect , psychiatry , alternative medicine , pathology
Berkovic SF, Knowlton RC, Leroy RF, Schiemann J, Falter U; On behalf of the Levetiracetam N01057 Study Group. Neurology . 2007;68 [Epub ahead of print]. 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.