Abstracts

Since 2000, a new objective and quantitative method in clinical seizure analysis was intriduced, which is called TISA (therapeutic intensive seizure analysis) (Stefan et al 2000). In supplement to the traditional seizure frequency, it introduces a new concept on the quantitative seizure severity D/24h, which represents the total duration of seizures per 24h within continuous video-EEG monitoring for the study phases. 24 patients with pharmacoresistant partial seizures who entered presurgical evaluation with conti nuous video-EEG monitoring in the center of epilepsy, Erlangen were enrolled in this study. The whole study phase was devided into a 48h baseline phase followed by a maximal 7-day treatment phase , which was unter continuous day-and-night video-EEG monitoring. After strict screening according to the inclusion criteria concerning age, diagnose, physical condition and complete information exchanges, eligible patients with maximal one AED stepped into the 48h basaeline phase. After at least two seizures with video-EEG evidence during the baseline phase these patients were randomized into the treatment phase receiving either verum or placebo. The daily dose of levetiracetam was 1000 mg (500 mg bid.) for the first treatment day, which was titrated to 2000 mg (100 mg bid.) from the second day on. The number and duration of seizures were exactly recorded based on the video-EEG and the duration of seizures per 24h (D/24h) were calculated. Uncover of the blindness was not done until the accomplishment of all planned patients. The blinded interim analysis showed
1) in 36 % of patients complete seizure control
2)in 27 % of patients more than 50 % decrease of D/24h (avarage 75 %),
3)increase of d/24h was observed in 24 %.
The final unblinded results will be presented. In this study the anticonvulsive effect of levetiracetam was evaluated as add-on therapy in pharmacoresistant focal epilepsies. The time window from the first drug dosage to the appearance of the clinical observable effects were analyzed.