[Safety of levetiracetam as adjunctive therapy in epilepsy: the SKATE trial in Spain].

AIM: To continue assessing safety and to evaluate the efficacy of levetiracetam and to assess the optimal dose in community based practice. PATIENTS AND METHODS: Single-arm, open label, multicenter, observational and prospective trial lasting 16-22 weeks. Criteria for inclusion: patients > 16 years experiencing epilepsy with partial seizures taking at least one concomitant antiepileptic drug. The initial dose was 1,000 mg/day, up to the maximal dose of 3,000 mg/day. Safety evaluation was adverse events reporting. Efficacy evaluation were reduction in seizure frequency; QOLIE-10 questionnaire and global evaluation scale of disease severity. RESULTS: Of the 342 subjects, 296 (86.5%) completed the treatment period. 103 subjects (30.1%) experienced at least one adverse event. The most frequently adverse events reported were somnolence (11.7%), dizziness (5.8%) and headache (3.5%). The events were majority (93.1%) of mild to moderate intensity. The median percent reduction in partial seizure frequency per week was 55%. 51.2% of patients experienced a reduction 50% in partial seizure frequency. Similar results were observed for total seizures. An increase of QOLIE-10 total score was observed (10.2 +/- 17.8). A total of 63.5% patients were rated as having moderate or marked improvement in their disease severity. CONCLUSIONS: These data confirm and provide additional support of levetiracetam safety and efficacy demonstrated in phase III trials.