Status:
RECRUITING
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Lead Sponsor:
Affiliated Hospital of Nantong University
Conditions:
Epilepsies, Partial
Epilepsy, Tonic-Clonic
Eligibility:
All Genders
1-14 years
Phase:
PHASE4
Brief 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 epi...
Detailed Description
This study primarily focuses on zonisamide, a drug originally developed as an antiepileptic and now used as an adjunctive treatment for focal epilepsy. Focal epilepsy is caused by abnormal electrical ...
Eligibility Criteria
Inclusion
- Consent to participate in the clinical trial, and the trial subject and/or legal guardian has signed the informed consent form.
- Age 1-14 years, no gender restrictions.
- Compliant with the diagnostic criteria for focal seizures and focal-to-bilateral tonic-clonic seizures as outlined by the International League Against Epilepsy (ILAE) in 2017.
- Stable on one antiepileptic drug for ≥4 weeks, and deemed to be appropriate for the addition of zonisamide therapy by the investigator.
- ≥ 2 episodes of generalized tonic-clonic seizures （secondary to focal epileptic seizures) per 28-day interval during the 8-week retrospective baseline period.
Exclusion
- History of zonisamide treatment.
- History of allergy to sulfonamide drugs, zonisamide or any excipients.
- History of drug/alcohol abuse.
- History of suicide attempt or suicidal ideation within the past 6 months.
- Current use of antidepressants, anxiolytics, or antipsychotics.
- Diagnosed with progressive diseases affecting the brain and its functions.
- Psychogenic non-epileptic seizures.
- Diagnosed with severe pulmonary/hematologic diseases, malignant tumors, immunodeficiency, or psychiatric illnesses.
- Have undergone epilepsy brain surgery or plan to undergo epilepsy surgery within the next 4 months.
- Deemed to be unsuitable for participation in the trial by the investigator.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06967012
Start Date
August 1 2024
End Date
July 31 2027
Last Update
May 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226000