A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epilepti… (NCT06967012) | Clinical Trial Compass
RecruitingPhase 4
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
China30 participantsStarted 2024-08-01
Plain-language 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?
Who can participate
Age range1 Year – 14 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.