Abstracts

Rationale: New onset focal epilepsy occurs frequently in the elderly, yet, randomised controlled studies on antiepileptic treatment are scarce. Lamotrigine (LTG) and gabapentin are of equal efficacy but better tolerability compared to CBZ standard release. Retention is not different to LTG when CBZ slow-release is used. In this trial Levetiracetam (LEV) is compared to CBZ-SR and LTG. Methods: STEP-ONE is a randomized, double-blind, multicenter study. Patients aged 60 years or above with new onset focal epilepsy (either at least one seizure and spike discharges on EEG or a relevant lesion on CT/MRI or a total of 2 spontaneous seizures) are eligible and those with symptomatic epileptic seizures due to acute (< 2 weeks) brain injuries are excluded. Patients receive CBZ-SR, LTG or LEV in a parallel group design over 58 weeks (6 weeks titration and 52 weeks maintenance, target 400, 100, 1000 mg, respectively). Results: Two hundred and sixty (n=260 of 360) patients have been included so far. The drop-out rate is 38.6%. Drop-out reasons include: 42% patients personal request, 27% side effects on lowest daily dose (CBZ-SR 200mg, LTG 50mg, and LEV 500mg), SAEs (18%), and 25% newly occurring medical conditions. There were no unexpected drug-related serious adverse events. We expect to include the last patient by spring 2010. Conclusions: Overall retention (61%) is comparable to previous trials. Antiepileptic treatment in the elderly requires slow titration on low target dosages. Data with standard CBZ and faster titration or high target dosages should be interpreted with caution. Special drug trial designs are needed for the elderly. Recruitment of elderly people is difficult but study adherence is good.