NCT06967012 A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
| NCT ID | NCT06967012 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Epilepsies, Partial |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-08-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06967012 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 14 Years, studying Epilepsies, Partial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06967012 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06967012 currently recruiting?
Yes, NCT06967012 is actively recruiting participants. Contact the research team at francis_nt@163.com for enrollment information.
Where is the NCT06967012 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT06967012 clinical trial?
NCT06967012 is sponsored by Affiliated Hospital of Nantong University. The trial plans to enroll 30 participants.