Abstracts

To conduct a prospective, open-label pilot trial to evaluate the efficacy and tolerability of Levetiracetam (LEV) monotherapy in a cohort of 10 children with benign childhood epilepsy with centrotemporal spikes (BECTS) in paying special attention to effects on cognitive function., Newly diagnosed patients with BECTS and patients with BECTS nonresponding to first-line monotherapy with Sulthiame (STM) were recruited from our clinics outpatients department. Inclusion criteria were proven diagnosis of BECTS, two ore more seizures in the last six months, age between 3 to 12 years and informed consent by parents. Patients with progressive neurological or systemic disease, other forms of epilepsy and moot compliance of caregivers were excluded from the trial. LEV was titrated up to 20 mg/kg. Efficacy was assessed by analysing changes in seizure frequency and alteration of electroencephalogram (EEG) abnormalities over a 6 months period. Therefore recordings of EEG during wakefulness and sleep were conducted before start of LEV treatment, after 1, 3 and 6 months. Neuropsychological testing of patients took place before start of LEV treatment and is to be repeated after 6 months of treatment. Tolerability was assessed by evaluation of LEV-associated adverse events (AE). Approval by the local ethics committee was obtained., To date 10 patients have been recruited, aged 3 to 12 years. 6/10 patients received LEV as first-line monotherapy. 4/10 patients were switched to LEV monotherapy from first-line monotherapy with STM due to inefficacy (3/4) and hyperventilation (1/4) respectively. At this time all of the LEV treated patients are seizure-free (8/10 have completed the 6 months period, 2/10 patients are still ongoing). EEG abnormalities showed remarkable reduction in all of the patients. Neuropsychological assessment in 9/10 patients before start of treatment revealed average performance in 7/9 and below average performance in 2/9 patients. In those 8 patients who have by now reached the endpoint of the trial no changes in neuopsychological parameters were seen. AEs were reported in 2/10 patients. 1 patient complaint of agitation within the first week of the LEV treatment, 1 patient developed hyporexia associated to mild weight loss within day 60 to 120 of treatment which resolved spontaneously., These preliminary data show that LEV seems to be an effective and well-tolerated option in the treatment of children with BECTS. Concerning effects on cognitive function preliminary data are promising. Based on these encouraging results a controlled, randomized, double-blind multicentre trial to evaluate the application of LEV in a representative cohort of 120 children with BECTS has started in Germany spring 2006 (HEAD-Study)., (Supported by UCB Pharmaceuticals.)