Evaluating zonisamide for treating focal epilepsy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the efficacy and safety of zonisamide as an add-on treatment for children aged 1-14 years with drug-resistant focal epilepsy. It involves an open-label, observational design where participants will gradually receive zonisamide, starting at 2 mg/kg/day and increasing to a maintenance dose based on their condition. The study aims to determine if zonisamide can reduce seizure frequency and improve cognitive function while monitoring for any adverse effects. A total of 30 patients will be recruited who have been stable on one antiepileptic drug but continue to experience seizures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: youjia Y Wu, Doctorate
• Email: francis_nt@163.com
• Phone: 13962969655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.