Zonegran® (zonisamide) is effective and well-tolerated as an adjunctive therapy in paediatric patients with partial-onset seizures, according to the results of a Phase III study presented on Wednesday at the International Epilepsy Congress in Rome, Italy.
The double-blind, randomised, multicentre, placebo-controlled study set out to assess the efficacy and safety/tolerability of adjunctive zonisamide in 207 paediatric patients (6-17 years) with partial-onset seizures who were on one or two anti-epileptic drugs.
The study’s primary endpoint was the proportion of responders (greater than or equal to 50% seizure frequency reduction) after 12 weeks maintenance treatment. Safety/tolerability evaluation included assessment of treatment-emergent adverse events (TEAEs).
“Evidence is quite strong that adjunctive zonisamide is more effective than placebo,” said Professor Renzo Guerrini, Children’s Hospital Anna Meyer, University of Florence, Italy.
“These results are definitely significant. There are a large proportion of children who do not get complete seizure control and have to take more than one type of anti-epileptic to reduce seizures.”
“We know that zonisamide is already a successful add-on treatment and is also very effective in newly diagnosed adults with epilepsy. I welcome these study results as they indicate that the paediatric population could stand to significantly benefit too.” The percentage of patients who completed the study was comparable between the zonisamide and placebo groups (86.9% patients on zonisamide and 90% patients on placebo).
Results showed that significantly more patients responded positively to treatment with zonisamide (50.5%) versus treatment with placebo (31.0%). Safety and tolerability assessments showed that the overall incidence of TEAEs was similar for zonisamide (55.1%) versus placebo (50.0%).
There were low rates of serious TEAEs in the zonisamide and placebo groups (3.7% vs 2.0%), and TEAEs leading to withdrawal from the study (0.9% vs 3.0%). TEAEs reported more frequently with zonisamide versus placebo were decreased appetite (6.5% vs 4.0%), decreased weight (4.7% vs 3.0%), somnolence (4.7% vs 2.0%), vomiting (3.7% vs 2.0%) and diarrhoea (3.7% vs 1.0%).