Tests zonisamide added to treatment for focal epileptic seizures
Tests oral zonisamide added to treatment in children with epilepsy.
Plain-language title generated from the registry record
Registry title: A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Key facts
- Where
- Nantong, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 14 years old?
Source: NCT06967012, who can take part
Where in China
- Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Affiliated Hospital of Nantong University
- Trial code
- NCT06967012
- Record updated
- 13 May 2025
- Original description
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:Read full original descriptionShow less
Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study
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?
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; 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; Current use of antidepressants, anxiolytics, or antipsychotics; Deemed to be unsuitable for participation in the trial by the investigator.