Phase III trial shows Zonegran for Epilepsy well tolerated in young patients - Eisai

Zonegran (zonisamide), from Eisai, is well tolerated and efficacious when used as an adjunctive (add-on) treatment for partial Epilepsy, with or without secondary generalisation, in children aged between 6-17 years for at least one year, according to the results of a new study published today in Epilepsia. The results of this study also showed that zonisamide was not associated with any unexpected safety issues or detrimental effects on children's growth and development.

The study was an open label extension of a Phase III, double-blind, randomised, placebo-controlled, multicentre trial. It set out to assess the long-term safety/tolerability and explore the long-term maintenance of efficacy of adjunctive zonisamide in 144 children aged 6-18 years from 10 European countries. The results of the study showed a low incidence of serious treatment-emergent adverse events (TEAEs) (2.1%) and TEAEs leading to discontinuation from the study (2.8%).

See: "Adjunctive zonisamide therapy in the long-term treatment of children with partial epilepsy: Results of an open-label extension of a phase III, randomised, double-blind, placebo-controlled trial." Guerrini R, et al. Epilepsia. doi: 10.1111/epi.12548