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

Launched by AFFILIATED HOSPITAL OF NANTONG UNIVERSITY · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called zonisamide as an additional treatment for children and young adults who experience focal epilepsy, which is a type of seizure that starts in one part of the brain. The researchers want to find out if taking zonisamide can reduce the number of seizures and improve thinking skills. They are also looking into whether there are any side effects from taking the medication.

To participate in this study, children aged 1 to 14 who have had at least two generalized tonic-clonic seizures (which are more severe and involve the whole body) in the last month may be eligible. They must be stable on one other seizure medication for at least four weeks and have consent from a parent or guardian. Participants will be monitored closely throughout the trial to track their seizure frequency and any potential side effects. This trial is currently recruiting participants, and it aims to provide important information about the safety and effectiveness of zonisamide in managing epilepsy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Consent to participate in the clinical trial, and the trial subject and/or legal guardian has signed the informed consent form.
• • 2. Age 1-14 years, no gender restrictions.
• • 3. 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.
• • 4. Stable on one antiepileptic drug for ≥4 weeks, and deemed to be appropriate for the addition of zonisamide therapy by the investigator.
• • 5. ≥ 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:
• • 1. History of zonisamide treatment.
• • 2. History of allergy to sulfonamide drugs, zonisamide or any excipients.
• • 3. History of drug/alcohol abuse.
• • 4. History of suicide attempt or suicidal ideation within the past 6 months.
• • 5. Current use of antidepressants, anxiolytics, or antipsychotics.
• • 6. Diagnosed with progressive diseases affecting the brain and its functions.
• • 7. Psychogenic non-epileptic seizures.
• • 8. Diagnosed with severe pulmonary/hematologic diseases, malignant tumors, immunodeficiency, or psychiatric illnesses.
• • 9. Have undergone epilepsy brain surgery or plan to undergo epilepsy surgery within the next 4 months.
• • 10. Deemed to be unsuitable for participation in the trial by the investigator.