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

Epilepsies, Partial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374966
• Other study ID #: 2024-0246
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yao Ding, doctorate
• Phone: 13588015954
• Email: tinady2002[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• Zonisamide
This is a real-world study,so we prospectively enrolled patients with focal epilepsy suitable for taking zonisamide as an add-on medication

Locations

Country	Name	City	State
China	Hangzhou Children's Hospital	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Huzhou Third People's Hospital	Huzhou	Zhejiang
China	Jiaxing Second hospital	Jiaxing	Zhejiang
China	Jinhua Second hospital	Jinhua	Zhejiang
China	The Fourth Affilicated Hospital of Zhejiang University School of Medicine	Jinhua	Zhejiang
China	Lishui People's Hospital	Lishui	Zhejiang
China	Ningbo Medical center Lihuili hospital	Ningbo	Zhejiang
China	Ningbo Women And Children's Hospital	Ningbo	Zhejiang
China	Yuyao People's hospital	Yuyao	Zhejiang

Sponsors (10)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou Children's Hospital, Huzhou Third People's Hospital, Jinhua Second Hospital, Lishui Country People's Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo Women & Children's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University, Yuyao People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective rate at 6 months of treatment	Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency	6 months
Secondary	Effective rate at 3 months of treatment	Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency	3 months
Secondary	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	6 months
Secondary	Incidence of side effects	Record the occurrence of side effects in patients and calculate the probability of each side effect occurring	6 months