Actively Recruiting
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Led by Affiliated Hospital of Nantong University · Updated on 2025-05-13
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consent to participate in the clinical trial, with signed informed consent from the participant and/or legal guardian
- Age between 1 and 14 years with no gender restrictions
- Diagnosed with focal seizures or focal-to-bilateral tonic-clonic seizures according to 2017 ILAE criteria
- Stable on one antiepileptic drug for at least 4 weeks and suitable for zonisamide addition as judged by the investigator
- Experienced 2 or more generalized tonic-clonic seizures secondary to focal epilepsy per 28-day period during the 8-week baseline
You will not qualify if you...
- Previous treatment with zonisamide
- Allergy to sulfonamide drugs, zonisamide, or any excipients
- History of drug or alcohol abuse
- Suicide attempt or suicidal thoughts within the past 6 months
- Current use of antidepressants, anxiolytics, or antipsychotics
- Progressive brain diseases affecting brain function
- Psychogenic non-epileptic seizures
- Severe lung or blood diseases, cancer, immunodeficiency, or psychiatric disorders
- History of epilepsy brain surgery or plans for surgery within the next 4 months
- Considered unsuitable for the trial by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226000
Actively Recruiting
Research Team
Y
youjia Y Wu, Doctorate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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