The SKATE study: interim analysis.

Abstract

The Safety of Keppra as Adjunctive Therapy in Epilepsy (SKATE) study is a continuing phase IV open-label evaluation of the antiepileptic drug levetiracetam (Keppra) as an adjunctive therapy in adult patients with uncontrolled partial seizures. The study, which began in April 2000, is scheduled to include 1400 patients from 300 centres in 16 countries. An interim analysis of the first 731 patients from 117 centres in nine countries treated over a 16-week period showed that seizure frequency was reduced by half or more in 49% of patients across all seizure types. A substantial 17.2% of patients achieved complete freedom from seizures. Levetiracetam was well tolerated overall. Adverse events were predominantly mild to moderate and rarely led to discontinuation. The most commonly reported symptoms were asthenia, somnolence, headache and dizziness.