NCT06967012RecruitingPhase 4
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study
Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 2 Feb 2025
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Epilepsy
- NCT number
- NCT06967012
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Aug 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Current use of antidepressants, anxiolytics, or antipsychotics.
- Deemed to be unsuitable for participation in the trial by the investigator.
Who the study is looking for
- 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.
Age in the registry: 1 year to 14 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.