A Phase 4 interventional study of Oral Zonisamide Therapy in Epilepsies, Partial and Epilepsy, Tonic-Clonic, sponsored by Affiliated Hospital of Nantong University. Recruiting at 1 site in China. Open to participants aged 1 Year to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Affiliated Hospital of Nantong University · Phase 4, Interventional, and Treatment
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:
This study primarily focuses on zonisamide, a drug originally developed as an antiepileptic and now used as an adjunctive treatment for focal epilepsy. Focal epilepsy is caused by abnormal electrical discharges in a specific area of the brain, which can lead to sudden loss of consciousness or muscle spasms. The main content of the study can be summarized as follows:
243 studies on the registry are indexed under Epilepsies, Partial; 49 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 187 interventional studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →Affiliated Hospital of Nantong University is the lead sponsor of 97 studies on the registry; 57 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg/kg/day, Weeks 3-4: 4 mg/kg/day, Weeks 5-6: 6 mg/kg/day. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg/kg/day. The maintenance dose ranges from 4 to 6 mg/kg/day, administered in 1-2 divided doses daily. Participants weighing ≥50 kg receive adult-equivalent dosing.
Drug: Oral Zonisamide Therapy
Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg/kg/day, Weeks 3-4: 4 mg/kg/day, Weeks 5-6: 6 mg/kg/day. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg/kg/day. The maintenance dose ranges from 4 to 6 mg/kg/day, administered in 1-2 divided doses daily. For children weighing ≥50 kg, the adult dosage should be used.
Primary Observational Indicators
Change in seizure frequency: The reduction in seizure frequency over an average of four weeks during the maintenance period, compared with the retrospective baseline period, in patients with focal epilepsy with or without secondary generalized tonic-clonic seizures.
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Primary Observational Indicators
≥50% response rate: The proportion of subjects achieving a ≥50% reduction in the average four-week seizure frequency during the maintenance period compared to the retrospective baseline period in patients with focal epilepsy with or without secondary generalized tonic-clonic seizures.
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Secondary Observational Indicators
1. The percentage of patients achieving seizure-free status during the maintenance period in patients with focal epilepsy with or without secondary generalized tonic-clonic seizures. 2. Retention rate: The percentage of patients who continue to take the medication within a specific time compared to the initial number of patients who started the medication.
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Weight (kg)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
blood pressure (mmHg)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Pulse (bpm)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Blood routine: WBC (/L), PLT (/L)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Liver function: ALT (U/L), AST (U/L), ALP (U/L)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Kidney function: Scr(μmol/L)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Blood routine: Hb (g/L)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Kidney function: UREA(mmol/L)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Liver function: TBIL (μmol/L)
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Plan to share: No
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Affiliated Hospital of Nantong University