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

ConditionsEpilepsies, Partial Epilepsy, Tonic-Clonic

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age1-14

SponsorAffiliated Hospital of Nantong University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Oral Zonisamide Therapy
Drug
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Monotherapy and add-on therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Primary Observational Indicators

Change in seizure frequency: The reduction in seizure frequency over an average of four weeks during the maintenance period, compared with the retrospective baseline period, in patients with focal epilepsy with or without secondary generalized tonic-clonic seizures.

Time frame