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

NCT06967012 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-13

No results posted yet for this study

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?

Conditions

  • Epilepsies, Partial
  • Epilepsy, Tonic-Clonic

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.

Sponsors & Collaborators

  • Affiliated Hospital of Nantong University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06967012 on ClinicalTrials.gov