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Multicenter Double‐Blind, Randomized, Placebo‐Controlled Trial of Levetiracetam as Add‐On Therapy in Patients with Refractory Partial Seizures
Author(s) -
Shorvon Simon D.,
Löwenthal Armand,
Janz Dieter,
Bielen Edith,
Loiseau Pierre
Publication year - 2000
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.2000.tb00323.x
Subject(s) - tolerability , placebo , medicine , adverse effect , levetiracetam , anesthesia , refractory (planetary science) , concomitant , somnolence , randomized controlled trial , placebo controlled study , epilepsy , double blind , psychiatry , physics , alternative medicine , pathology , astrobiology
Summary:Purpose : To evaluate the efficacy and tolerability of levetiracetam (LEV, Keppra) as add‐on therapy in patients with refractory partial seizures. Methods : In this European multicenter, double‐blind, randomized, placebo‐controlled trial, LEV (500 or 1,000 mg twice daily) was compared with placebo as add‐on therapy in 324 patients with uncontrolled simple or complex partial seizures, or both, with or without secondary generalization. After enrollment, three parallel groups were assessed during a baseline period of 8 or 12 weeks, followed by a 4‐week titration interval and a 12‐week evaluation period. Results : LEV significantly decreased partial seizure frequency compared with placebo. A reduction in seizure frequency of 50% occurred in 22.8% of patients in the 1,000‐mg group and 31.6% of patients in the 2,000‐mg group, compared with 10.4% of patients in the placebo group. Administration of LEV did not affect plasma concentrations of concomitant an‐tiepileptic drugs or alter vital signs or laboratory parameters. No significant difference in the incidence of adverse events was observed between treatment groups (70.8% for the 1,000‐mg group and 75.5% for the 2,000‐mg group), or between the LEV and placebo groups (73.2% for placebo group). The most commonly reported adverse effects in the LEV group were asthenia, headache, and somnolence. Conclusions : The antiepileptic efficacy and tolerability of LEV (1,000 mg/d and 2,000 mg/d, administered in two divided doses) as add‐on therapy was established in patients with refractory partial seizures in this clinical study.