A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
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
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
Treatments tested in this trial
- Oral Zonisamide Therapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov