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RECRUITING
NCT06967012
PHASE4

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

Sponsor: Affiliated Hospital of Nantong University

View on ClinicalTrials.gov

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?

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

Key Details

Gender

All

Age Range

1 Year - 14 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-08-01

Completion Date

2027-07-31

Last Updated

2025-05-13

Healthy Volunteers

Yes

Interventions

DRUG

Oral 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.

Locations (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China