RecruitingPhase 4NCT06967012

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

Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study

Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Epilepsy, Tonic-Clonic Epilepsies, Partial

Summary

This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are: 1. Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function? 2. Are there any treatment-emergent adverse events associated with oral administration of zonisamide?

Eligibility

Min Age: 1 YearMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral Zonisamide Therapy for people with epilepsies, partial and epilepsy, tonic-clonic. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOral Zonisamide Therapy

Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg/kg/day, Weeks 3-4: 4 mg/kg/day, Weeks 5-6: 6 mg/kg/day. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg/kg/day. The maintenance dose ranges from 4 to 6 mg/kg/day, administered in 1-2 divided doses daily. For children weighing ≥50 kg, the adult dosage should be used.