Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT06967012
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
14 Years
Study:
NCT06967012
Study Brief:
Protocol Section:
NCT06967012