RecruitingPhase 4NCT06967012

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

Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study

Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Epilepsy, Tonic-Clonic Epilepsies, Partial

Summary

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?

Eligibility

Min Age: 1 YearMax Age: 14 Years

Inclusion Criteria5

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 Criteria10

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.

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Interventions

DRUGOral Zonisamide Therapy

Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg/kg/day, Weeks 3-4: 4 mg/kg/day, Weeks 5-6: 6 mg/kg/day. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg/kg/day. The maintenance dose ranges from 4 to 6 mg/kg/day, administered in 1-2 divided doses daily. For children weighing ≥50 kg, the adult dosage should be used.