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

Más betegség

• 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.
• 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.

Egyéb

• Current use of antidepressants, anxiolytics, or antipsychotics.
• Deemed to be unsuitable for participation in the trial by the investigator.

• 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.