Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

ClinicalTrials.gov ID

NCT06374966

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

400Estimated

Last Update Posted

Apr 19, 2024Actual

Start Date

Apr 2024Estimated

Primary Completion Date

Sep 2025Estimated

Completion Date

Dec 2025Estimated

Official Title

Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

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.

Detailed Description

1. 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.
2. 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.
3. 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.

• Epilepsies, Partial

• Zonisamide

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. 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;
2. Be greater than or equal to 2 years of age;
3. 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;
4. 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;
5. The informed consent form was signed and dated by the patient or a parent or legal guardian.

Exclusion Criteria:

1. Patients who are allergic to zonisamide ;
2. CT or MRI suggestive of progressive intracranial tumours;
3. Severe mental retardation or severe psychiatric disorders;
4. 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;
5. Ultrasound suggestive of renal stones 6) Pregnant or breastfeeding

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Collaborators

Hangzhou Children's HospitalUNKNOWN

The Fourth Affiliated Hospital of Zhejiang University School of MedicineOTHER

Jinhua Second HospitalUNKNOWN

Ningbo Medical Center Lihuili HospitalOTHER_GOV

Ningbo Women & Children's HospitalOTHER

Yuyao People's HospitalOTHER

Huzhou Third People's HospitalOTHER

The Second Affiliated Hospital of Jiaxing UniversityOTHER

Lishui Country People's HospitalOTHER

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