A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Recruiting · NCT06967012 · Interventional (participants receive a specific treatment) · Lead sponsor: Affiliated Hospital of Nantong University
View the official record on ClinicalTrials.gov →Interventions studied
Oral Zonisamide Therapy
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?
Who can take part
Age range
1 Year to 14 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Affiliated Hospital of Nantong University - Nantong, Jiangsu, China