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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
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
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