Assessing the Safety and Effectiveness of Zonisamide as First Add-On Treatment for Children with Focal and Secondary Generalized Epileptic Seizures

What This Trial Is About

Researchers are evaluating the effectiveness and safety of zonisamide as an additional treatment for children aged 1 to 14 years with focal epilepsy, including those with secondary generalized tonic-clonic seizures. The study aims to determine whether zonisamide can reduce the frequency of epileptic seizures and improve cognitive function, while also monitoring any treatment-related side effects. This open-label, observational study focuses on patients who have not achieved adequate seizure control with one antiepileptic drug. Participants will receive zonisamide tablets orally, starting at 2 mgkgday during the first two weeks. The dose increases to 4 mgkgday in weeks 3-4 and to 6 mgkgday in weeks 5-6. After six weeks, the dose is adjusted weekly by 1 mgkgday based on the patients condition, maintaining a dose between 4 and 6 mgkgday given once or twice daily. Children weighing 50 kg or more will receive adult-equivalent dosing. During the study, participants seizure frequency and cognitive function will be assessed at baseline, week 8, and week 20. Safety will be monitored through physical exams, vital signs, weight checks, and laboratory tests including liver and kidney function and blood counts. The study will use statistical software to analyze changes in seizure frequency and safety data. The total study duration is from August 1, 2024, to July 31, 2027.

A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures