Abstracts

Rationale: The elderly are the fastest growing segment of people with newly diagnosed epilepsy with incidence rates of up to 200/100000/year. Up to now two randomized clinical trials have demonstrated equal efficay but better tolerability of lamotrigine (LTG; 2 trials) and gabapentin (GBP; 1 trial) in comparison to carbamazepine standard release. However, another trial comparing carbamazepine extended release (CBZ-ER) and LTG did not find any significant differences. Levetiracetam (LEV) has not been studied in a controlled trial speficically in the elderly up to now. We started an investigator initiated trial comparing CBZ-ER with LTG and LEV. Methods: STEP-ONE is a multicentre, double-blind, randomized trial in people with newly diagnosed epilepsy aged at least 60 years. The study is performed in > 70 centers in the three major German speaking countries (Germany, Austria, and Switzerland).Outcome parameter are the efficacy, tolerability and safety of CBZ-ER, LTG, and LEV. The study design is availabe at the internet (http://www.step-one.eu). Principal investigator is Dr. Konrad Werhahn, national coordinators are Dr. Eugen Trinka for Austria and Dr. Günter Krämer for Switzerland. Results: In September 2006 the first center was initiated and the first patient was included in March 2007. The average recruitment rate is 20 per months and the study results can be expected at the beginning of 2010. Up to now 160 patients have been randomized, of whom 46 (= 28.8%) dropped out. The drop out rate is lower than initially expected. Conclusions: STEP ONE is the first double blind randomized clinical trial including LEV for elderly people with epilepsy. Recruitment is still ongoing. The dropout rates up to now are rather low in comparison to earlier trails with carbamazepine standard release.