Epilepsies, PartialPhase 4NCT06967012
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
A Phase 4 study testing Oral Zonisamide Therapy in people with Epilepsies, Partial and Epilepsy, Tonic-Clonic, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
- What is being tested?
- Oral Zonisamide Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- Current use of antidepressants, anxiolytics, or antipsychotics.
- Diagnosed with progressive diseases affecting the brain and its functions.
Show all 10Show fewer
- 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.
- Deemed to be unsuitable for participation in the trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
youjia Y Wu, Doctorate, +8613962969655, francis_nt@163.com
About this study
Official title: Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study
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:
- Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function?
- Are there any treatment-emergent adverse events associated with oral administration of zonisamide?
Read the detailed description
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:
- Research Purpose: To evaluate the efficacy and safety of zonisamide as an adjunctive treatment for focal epilepsy, especially for drug-resistant focal epilepsy.
- Study Design: This is an open-label, observational study without a control group, planning to recruit 30 patients aged 1-14 years who have been stably taking one antiepileptic drug in the past 4 weeks but with poor results, and are now being considered for zonisamide treatment.
- Treatment Plan: Patients will receive a gradually increasing dose of zonisamide, starting at 2 mg/kg/day and titrating up to 6 mg/kg/day, followed by a maintenance dose of 4-6 mg/kg/day depending on the patient's condition.
- Effectiveness Evaluation: The efficacy of zonisamide is mainly assessed by comparing the change in seizure frequency before and after treatment and the proportion of patients whose seizure frequency is reduced by more than 50%.
- Safety Assessment: The safety of zonisamide is assessed through physical examinations, weight monitoring, vital sign monitoring, and laboratory tests (including liver and kidney function and CBC).
- Statistical Methods: Data analysis will be performed using SAS 9.4 statistical software, incorporating both descriptive and inferential statistics to assess the statistical significance of treatment effects.
- Research Duration: August 1, 2024-July 31, 2027. This study is significant for exploring the potential of zonisamide as a new treatment plan, especially in combating epilepsy seizures that are difficult to control with traditional drugs.
- Conditions
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
- Being tested
- Oral Zonisamide Therapy
- Keywords
- Zonisamide, Epilepsies, Partial, Epilepsy, Tonic-Clonic
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Zonisamide TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy and add-on therapy | Experimental | 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. Receives: Drug: Oral Zonisamide Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Secondary outcomes (10)
Secondary Observational Indicators
- 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.
- 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.
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Weight (kg)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
blood pressure (mmHg)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Pulse (bpm)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Blood routine: WBC (/L), PLT (/L)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Liver function: ALT (U/L), AST (U/L), ALP (U/L)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Kidney function: Scr(μmol/L)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Blood routine: Hb (g/L)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Kidney function: UREA(mmol/L)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Liver function: TBIL (μmol/L)
Measured: Week 0±7day, Week 8±7day, Week 20±7day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967012
- Sponsor's protocol ID
- 2024-K171-02
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho D, Yu MS, Shin J, Lee J, Kim Y, Kang HC, Kim SH, Na D. A computational clinical decision-supporting system to suggest effective anti-epileptic drugs for pediatric epilepsy patients based on deep learning models using patient's medical history. BMC Med Inform Decis Mak. 2024 May 31;24(1):149. doi: 10.1186/s12911-024-02552-w.
PubMed 38822293
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study
- ClinicalTrials.gov ID
- NCT06967012
- Acronym / sponsor ID
- 2024-K171-02
- Conditions
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
- Keywords
- Zonisamide, Epilepsies, Partial, Epilepsy, Tonic-Clonic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function?
- Are there any treatment-emergent adverse events associated with oral administration of zonisamide?
Detailed description
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:
- Research Purpose: To evaluate the efficacy and safety of zonisamide as an adjunctive treatment for focal epilepsy, especially for drug-resistant focal epilepsy.
- Study Design: This is an open-label, observational study without a control group, planning to recruit 30 patients aged 1-14 years who have been stably taking one antiepileptic drug in the past 4 weeks but with poor results, and are now being considered for zonisamide treatment.
- Treatment Plan: Patients will receive a gradually increasing dose of zonisamide, starting at 2 mg/kg/day and titrating up to 6 mg/kg/day, followed by a maintenance dose of 4-6 mg/kg/day depending on the patient's condition.
- Effectiveness Evaluation: The efficacy of zonisamide is mainly assessed by comparing the change in seizure frequency before and after treatment and the proportion of patients whose seizure frequency is reduced by more than 50%.
- Safety Assessment: The safety of zonisamide is assessed through physical examinations, weight monitoring, vital sign monitoring, and laboratory tests (including liver and kidney function and CBC).
- Statistical Methods: Data analysis will be performed using SAS 9.4 statistical software, incorporating both descriptive and inferential statistics to assess the statistical significance of treatment effects.
- Research Duration: August 1, 2024-July 31, 2027. This study is significant for exploring the potential of zonisamide as a new treatment plan, especially in combating epilepsy seizures that are difficult to control with traditional drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy and add-on therapy | Experimental | Drug: Oral Zonisamide TherapyZonisamide 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. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Current use of antidepressants, anxiolytics, or antipsychotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Zonisamide TherapyZonisamide 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. | Drug | Monotherapy and add-on therapy |
Primary outcome
Primary Observational Indicators
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
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.
Primary Observational Indicators
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
≥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.
10 secondary outcomes
Secondary Observational Indicators
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Safety Evaluation
Time frame: Week 0±7day, Week 8±7day, Week 20±7day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 38822293Cho D, Yu MS, Shin J, Lee J, Kim Y, Kang HC, Kim SH, Na D. A computational clinical decision-supporting system to suggest effective anti-epileptic drugs for pediatric epilepsy patients based on deep learning models using patient's medical history. BMC Med Inform Decis Mak. 2024 May 31;24(1):149. doi: 10.1186/s12911-024-02552-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Zonisamide Therapy in people with Epilepsies, Partial and Epilepsy, Tonic-Clonic, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact youjia Y Wu, Doctorate (13962969655, francis_nt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Observational Indicators (time frame: Week 0±7day, Week 8±7day, Week 20±7day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06967012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.