Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy
1 other identifier
observational
400
1 country
10
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 19, 2024
April 1, 2024
1.4 years
April 16, 2024
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective rate at 6 months of treatment
Effective definition: achievement of clinical seizure freedom or \>50% reduction in seizure frequency
6 months
Secondary Outcomes (3)
Effective rate at 3 months of treatment
3 months
Total time to treatment failure
6 months
Incidence of side effects
6 months
Study Arms (1)
Patients with focal epilepsy
who using zonisamide as an add-on anti-seizure drug
Interventions
This is a real-world study，so we prospectively enrolled patients with focal epilepsy suitable for taking zonisamide as an add-on medication
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Hangzhou Children's Hospitalcollaborator
- The Fourth Affiliated Hospital of Zhejiang University School of Medicinecollaborator
- Jinhua Second Hospitalcollaborator
- Ningbo Medical Center Lihuili Hospitalcollaborator
- Ningbo Women & Children's Hospitalcollaborator
- Yuyao People's Hospitalcollaborator
- Huzhou Third People's Hospitalcollaborator
- The Second Affiliated Hospital of Jiaxing Universitycollaborator
- Lishui Country People's Hospitalcollaborator
Study Sites (10)
Hangzhou Children's Hospital
Hangzhou, Zhejiang, 310005, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Huzhou Third People's Hospital
Huzhou, Zhejiang, 313002, China
Jiaxing Second hospital
Jiaxing, Zhejiang, 314099, China
Jinhua Second hospital
Jinhua, Zhejiang, 321016, China
The Fourth Affilicated Hospital of Zhejiang University School of Medicine
Jinhua, Zhejiang, 322099, China
Lishui People's Hospital
Lishui, Zhejiang, 323050, China
Ningbo Women And Children's Hospital
Ningbo, Zhejiang, 315012, China
Ningbo Medical center Lihuili hospital
Ningbo, Zhejiang, 315048, China
Yuyao People's hospital
Yuyao, Zhejiang, 315499, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuang Wang, doctorate
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 19, 2024
Study Start
April 1, 2024
Primary Completion
September 1, 2025
Study Completion
December 1, 2025
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share