Abstracts

Rationale: The primary aim of the study was to investigate how many children and adolescents with symptomatic and cryptogenic focal epilepsy benefit from Levetiracetam (LEV) as comedcation and how many of them respond to LEV without loss of efficacy after conversion to monotherapy. In addition, the influence of LEV on behaviour and quality of life of the children was investigated. Methods: Children and adolescents with a minimum of 2 seizures in 4 weeks, who were treated with 1 or 2 anticonvulsants (AED) were included. In a prospective, open, investigator initiated, multicenter study, LEV was added as comedication for 16 weeks (phase 1). If patients already treated with 2 AEDs one has been reduced and withdrawn in parallel. Patients who had a reduction of seizure frequency > 50% should be converted to LEV monotherapy for 16 weeks (phase 2). Results: Overall 87 patients (mean age 10.7 +/- 4.3 years; range: 1.6 - 17.9 years) had been recruited from 13 centres. They had been treated without sufficient efficacy with different AED (mean number: 3.5 +/- 2.1; range: 1 - 10) before. In 29 patients (33.3 %) the study was stopped during phase 1, mostly due to increase of seizure frequency (n=28). In 36 (41.4 %) children the seizure frequency has been reduced > 50% with LEV add on therapy, 22 showed no effect. 37 patients (42.5 %) had been converted to LEV monotherapy (phase 2). Most of those patients (n=17, 45.9 %) hadn’t had a clinically relevant change of seizure frequency (< 25%) after conversion to monotherapy compared to comedication with LEV, but some (n=4, 10.8%) had less seizures with LEV monotherapy. 5 children (13.5%) had an increase of seizure frequence. 11 (29.7 %) patients dropped out during phase 2, mainly due to increase of seizure frequency (n=9). Serious adverse events (n=11) were reported in 9 patients, in most cases without a definite relation to the therapy (unlikely: n=6, possible: n=3, probable: n=1, definite: n=1). The most frequently reported adverse effects were tiredness (n=25), aggressiveness (n=15), agitation (n=12), and disturbed concentration (n=12). In 17 children behavioral disturbances were the reason to stop LEV. Conclusions: In total, 21 of 37 children and adolescents (56.7%) who had benefited from a combination with LEV and who had been converted to a LEV monotherapy continued to have a seizure reduction >50% compared to the baseline (without LEV). This indicates that most (but not all) children who benefit from LEV comedication could also benefit from LEV monotherapy. The study was supported by UCB.