Evaluating zonisamide for treating focal epilepsy in children

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 is testing if adding zonisamide to the treatment of children aged 1-14 with hard-to-control focal epilepsy can help reduce their seizures and improve their thinking skills.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 1 Year to 14 Years
• Sex: All
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT06967012 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 1-14 years with drug-resistant focal epilepsy who have been stable on one antiepileptic drug for at least 4 weeks.

Not a fit: Patients with a history of zonisamide treatment or those with specific contraindications, such as allergies to sulfonamide drugs, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce seizure frequency and improve the quality of life for children with focal epilepsy.

How similar studies have performed: Other studies have shown promise in using zonisamide for epilepsy treatment, indicating potential for success in this approach.

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.

Where this trial is running

Nantong, Jiangsu

• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: youjia Y Wu, Doctorate

Conditions Epilepsies, Partial; Epilepsy, Tonic-Clonic; Zonisamide