Dupont S, Striano S, Trinka E, Springub J, Giallonardo AT, Smith P, Ellis S, Yeates A, Baker G. Flexible dosing of adjunctive zonisamide in the treatment of adult partial‐onset seizures: a non‐comparative, open‐label study (ZEUS).
Acta Neurol Scand: 2010: 121: 141–148.
© 2009 The Authors Journal compilation © 2009 Blackwell Munksgaard.
Objectives – To assess the efficacy and tolerability of zonisamide in a study allowing flexible dosing in a more diverse and less refractory population than assessed in randomized controlled trials.
Methods – This 19‐week, non‐comparative study of adjunctive zonisamide included 281 adults who had at least four partial‐onset seizures within 8 weeks on one or two antiepileptic drugs. Alterations to zonisamide doses were allowed after titration, except during two fixed‐dose periods (weeks 10–13 and 16–19).
Results – At the end of the second fixed‐dose period (median dose 300 mg/day), the median reduction in monthly seizure frequency was 33.3–41.1%; ≥50% responder rate was 40.9–44.2%; and seizure freedom rate was 15.0–15.9%, depending on the analysis used. The most common adverse events were fatigue (16.7%) and somnolence (15.3%).
Conclusions – Zonisamide demonstrated efficacy in a setting more reflective of clinical practice and was generally well tolerated.