Phase III study of Zonegran (Eisai) in younger patients with Epilepsy shows treatment benefits

Results from a pivotal Phase III study of Zonegran (zonisamide), from Eisai, in patients aged 6-17 years with partial Epilepsy indicate that the treatment is effective. In the double-blind, placebo-controlled, multicentre trial, 207 children with partial Epilepsy, receiving one or two antiepileptic drugs, were randomised to receive either adjunctive once-daily zonisamide or placebo. The primary efficacy end point was the proportion of responders (defined as greater than 50% seizure frequency reduction from baseline) during the 12-week maintenance period.

The responder rates were found to be 50% for zonisamide vs. 31% for placebo. The overall incidence of treatment emergent adverse events was similar for zonisamide (55.1%) vs. placebo (50.0%), with low rates of serious AEs in both arms of the study (3.7% zonisamide vs. 2.0% placebo) and AEs leading to withdrawal (0.9% vs. 3.0%). Results are published in Epilepsia. See: "A randomized, phase III trial of adjunctive zonisamide in pediatric patients with partial epilepsy." Guerrini R et al. Epilepsia, 9 July 2013 DOI: 10.1111/epi.12233