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 range
1 Year – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.