• J Salas-Puig, J M Serratosa, C Viteri, A Gil-Nágel-Rein, and Grupo Español del Estudio SKATE.
• Hospital Central de Asturias, Oviedo, Spain. jsalasp@meditex.es
• Rev Neurol. 2004 Jun 16; 38 (12): 1117-22.

AimTo continue assessing safety and to evaluate the efficacy of levetiracetam and to assess the optimal dose in community based practice.Patients And MethodsSingle-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.ResultsOf 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.ConclusionsThese data confirm and provide additional support of levetiracetam safety and efficacy demonstrated in phase III trials.

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