Epilepsies, PartialNCT06374966
Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy
An observational study of Epilepsies, Partial, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 10 sites in China.
Trial summary
Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Zonisamide
- How many people
- 400 participants
- Where
- 10 sitesChina
- Study dates
- Apr 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: As this is a real-world study,we prospectively enrolled patients with focal epilepsy who are suitable for taking zonisamide as an add-on medication
Who may be able to join
- Meet the International League Against Epilepsy 2017 diagnostic criteria for epilepsy; and the patient's seizures can be clearly classified as partial seizures according to the seizure classification proposed by the International League Against Epilepsy, including simple partial seizures, complex partial seizures, and secondary generalised seizures;
- Be greater than or equal to 2 years of age;
- Have been on antiepileptic medication, and during the 4-week period of the retrospective baseline period, the patient did not medication adjustments and had at least 2 seizures greater than or equal to 2 seizures per 4-week period;
- The patient demonstrated good compliance and was able to complete the scale assessment and record the epilepsy diary on his/her own or with the assistance of a parent;
- The informed consent form was signed and dated by the patient or a parent or legal guardian.
Who cannot join
- Patients who are allergic to zonisamide ;
- CT or MRI suggestive of progressive intracranial tumours;
- Severe mental retardation or severe psychiatric disorders;
- Patients suffering from serious underlying diseases that can affect brain function, such as heart disease, liver disease, renal disease, haematological disorders, malignant tumours, and patients who are immunocompromised;
- Ultrasound suggestive of renal stones 6) Pregnant or breastfeeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Hangzhou Children's Hospital
Hangzhou, Zhejiang, 310005
Zhanli Liu, doctorate, 15968194368, liuzhanli@126.com
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Shuang Wang, doctorate, 13588817561, wangs77@zju.edu.cn
Huzhou Third People's Hospital
Huzhou, Zhejiang, 313002
Changguo Zhang, doctorate, 15957288075, zhangcg1981@163.com
Jiaxing Second hospital
Jiaxing, Zhejiang, 314099
Xiaoxiang Yu, doctorate, 13567340650, 43262048@qq.com
Jinhua Second hospital
Jinhua, Zhejiang, 321016
Suhong Ye, doctorate, 13757990511, 1073774376@qq.com
The Fourth Affilicated Hospital of Zhejiang University School of Medicine
Jinhua, Zhejiang, 322099
Jiajia Fang, doctorate, 15215880868, fangjjiaj@zju.edu.cn
Lishui People's Hospital
Lishui, Zhejiang, 323050
Likang Lan, doctorate, 18957090351, lsllk67@163.com
Ningbo Women And Children's Hospital
Ningbo, Zhejiang, 315012
Minghai Huang, doctorate, 13605742462, hmhai432@126.com
Ningbo Medical center Lihuili hospital
Ningbo, Zhejiang, 315048
Xiaoqin Fan, doctorate, 13685739576, fanteacher@163.com
Yuyao People's hospital
Yuyao, Zhejiang, 315499
About this study
Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition.
Read the detailed description
- Before starting zonisamide treatment, a 4-week baseline observation period is required, which needs to meet the following criteria: no medication adjustment and at least 2 times of seizure per 4 weeks.
- If patients meet the criteria for the baseline period, after the baseline observation period, they are required to complete the blood routine, urine routine, renal function, liver function, ultrasound of the urinary tract, and scale completion (including the QOLIE-31 quality of life scale, GAD-7, C-NDDI-E, Pittsburgh sleep quality, and the Epworth Sleepiness Scale (ESS)) prior to initiating treatment. If the patient still meets the inclusion criteria, zonisamide may be added to the treatment, and the patient's seizures and medications prior to zonisamide treatment will be recorded.
- Outpatient follow-up and scale filling were carried out in the 1st, 3rd and 6th month of zonisamide treatment, and blood tests were reviewed in the first/third (according to the clinical situation) and sixth month, and urological ultrasound was reviewed in the sixth month, and imaging and electrophysiological examinations were carried out according to the clinical need in the light of the actual situation of the patients, and the changes of seizures and side effects during the medication period were recorded in detail.
- Conditions
- Epilepsies, Partial
- Being tested
- Zonisamide
- Keywords
- epilepsy, zonisamide
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
This is a real-world study，so we prospectively enrolled patients with focal epilepsy suitable for taking zonisamide as an add-on medication
| Study group | Role | What they receive |
|---|---|---|
| Patients with focal epilepsy | who using zonisamide as an add-on anti-seizure drug Receives: Drug: Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate at 6 months of treatment
Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency
Measured: 6 months
Secondary outcomes (3)
Effective rate at 3 months of treatment
Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency
Measured: 3 months
Total time to treatment failure
Total time to treatment failure: number of days from initiation of zonisamide to decision to withdraw zonisamide/add new antiepileptic medication
Measured: 6 months
Incidence of side effects
Record the occurrence of side effects in patients and calculate the probability of each side effect occurring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Children's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Jinhua Second Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo Women & Children's Hospital, Yuyao People's Hospital, Huzhou Third People's Hospital, The Second Affiliated Hospital of Jiaxing University, Lishui Country People's Hospital
- Responsible party
- Sponsor
- Investigators
- Shuang Wang, doctorate, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374966
- Sponsor's protocol ID
- 2024-0246
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy
- ClinicalTrials.gov ID
- NCT06374966
- Acronym / sponsor ID
- 2024-0246
- Conditions
- Epilepsies, Partial
- Keywords
- epilepsy, zonisamide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Children's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Jinhua Second Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo Women & Children's Hospital, Yuyao People's Hospital, Huzhou Third People's Hospital, The Second Affiliated Hospital of Jiaxing University, Lishui Country People's Hospital
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (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.
Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition.
Detailed description
- Before starting zonisamide treatment, a 4-week baseline observation period is required, which needs to meet the following criteria: no medication adjustment and at least 2 times of seizure per 4 weeks.
- If patients meet the criteria for the baseline period, after the baseline observation period, they are required to complete the blood routine, urine routine, renal function, liver function, ultrasound of the urinary tract, and scale completion (including the QOLIE-31 quality of life scale, GAD-7, C-NDDI-E, Pittsburgh sleep quality, and the Epworth Sleepiness Scale (ESS)) prior to initiating treatment. If the patient still meets the inclusion criteria, zonisamide may be added to the treatment, and the patient's seizures and medications prior to zonisamide treatment will be recorded.
- Outpatient follow-up and scale filling were carried out in the 1st, 3rd and 6th month of zonisamide treatment, and blood tests were reviewed in the first/third (according to the clinical situation) and sixth month, and urological ultrasound was reviewed in the sixth month, and imaging and electrophysiological examinations were carried out according to the clinical need in the light of the actual situation of the patients, and the changes of seizures and side effects during the medication period were recorded in detail.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with focal epilepsy | – | Drug: Zonisamidewho using zonisamide as an add-on anti-seizure drug |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As this is a real-world study,we prospectively enrolled patients with focal epilepsy who are suitable for taking zonisamide as an add-on medication
Key inclusion criteria (5 listed)
- Meet the International League Against Epilepsy 2017 diagnostic criteria for epilepsy; and the patient's seizures can be clearly classified as partial seizures according to the seizure classification proposed by the International League Against Epilepsy, including simple partial seizures, complex partial seizures, and secondary generalised seizures;
- Be greater than or equal to 2 years of age;
- Have been on antiepileptic medication, and during the 4-week period of the retrospective baseline period, the patient did not medication adjustments and had at least 2 seizures greater than or equal to 2 seizures per 4-week period;
- The patient demonstrated good compliance and was able to complete the scale assessment and record the epilepsy diary on his/her own or with the assistance of a parent;
- The informed consent form was signed and dated by the patient or a parent or legal guardian.
Key exclusion criteria (5 listed)
- Patients who are allergic to zonisamide ;
- CT or MRI suggestive of progressive intracranial tumours;
- Severe mental retardation or severe psychiatric disorders;
- Patients suffering from serious underlying diseases that can affect brain function, such as heart disease, liver disease, renal disease, haematological disorders, malignant tumours, and patients who are immunocompromised;
- Ultrasound suggestive of renal stones 6) Pregnant or breastfeeding
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 |
|---|---|---|
| ZonisamideThis is a real-world study，so we prospectively enrolled patients with focal epilepsy suitable for taking zonisamide as an add-on medication | Drug | Patients with focal epilepsy |
Primary outcome
Effective rate at 6 months of treatment
Time frame: 6 months
Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency
3 secondary outcomes
Effective rate at 3 months of treatment
Time frame: 3 months
Total time to treatment failure
Time frame: 6 months
Incidence of side effects
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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. This study is not recruiting at the moment.
Shuang Wang, doctorate principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Partial, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 10 sites 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 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Ding, doctorate (13588015954, tinady2002@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate at 6 months of treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.