LAMOTRIGINE VERSUS LEVETIRACETAM IN THE INITIAL MONOTHERAPY OF EPILEPSY - RESULTS OF THE LALIMO-STUDY - AN OPEN RANDOMIZED CONTROLLED HEAD TO HEAD PHASE 3B TRIAL INCLUDING 410 PATIENTS
Abstract number :
1.242
Submission category :
7. Antiepileptic Drugs
Year :
2008
Submission ID :
8967
Source :
www.aesnet.org
Presentation date :
12/5/2008 12:00:00 AM
Published date :
Dec 4, 2008, 06:00 AM
Authors :
Felix Rosenow, Sebastian Bauer, P. Reif, K. Klein, H. Hamer, C. Schade-Brittinger, Y. Burchardi, Y. Weber, H. Lerche, Stephan Arnold, Anja Beige, S. Evers, U. Reuner, G. Winckler, J. Springub, M. Niedhammer, E. Roth, I. Eisensehr, M. Schröder and J.
Rationale: Immediate seizure control is important to prevent injury and deterioration of the patients socio-economic situation. Patients are likely to take AEDs for several years. The purpose of this study was to compare efficacy and tolerability of LTG and LEV in the initial monotherapy of patients aged 12 or above with epilepsy or a first seizure with high risk of recurrence. Methods: Open, prospective, randomised multicenter comparative 26 week study. Patients were titrated to an initial dose of 2000mg of LEV reached on day 22 or 200mg of LTG reached on day 71. Dose adjustments in up to two 500/50mg steps were allowed. The Primary endpoint: proportion of patients seizure free at 6 weeks. Secondary endpoints: seizure free patients during the last 16 weeks, time to first seizure, quality of life, safety/tolerability. The confirmatory analysis was based on ITT-population (primarily) and per-protocol population using a two-sided Fisher's exact test (a=0.05). Results: 410 patients were included by 58 centers. Data of 368 patients are currently available. Demographic data for the LEV/LTG groups were: n=187/181, mean age:38.8/39.1; age 12->18:16/14, age 18-<60:142/136; age>
Antiepileptic Drugs