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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe a medication called zonisamide is when added to the treatment of patients with focal epilepsy, which is a type of epilepsy characterized by seizures that start in one specific area of the brain. The study will involve patients who have had at least two seizures in a four-week period and have been taking other epilepsy medications without any changes during that time. Participants must be at least two years old and capable of keeping a diary to track their seizures, either on their own or with help from a parent or guardian.

If you or your loved one is eligible and chooses to participate, the study will require a baseline observation period to monitor seizure frequency before starting zonisamide. After that, participants will take the medication and have regular check-ups at one, three, and six months to assess how well it is working and to monitor any side effects. It's important to note that individuals with certain health conditions, allergies to zonisamide, or those who are pregnant or breastfeeding cannot join the study. This trial is currently not recruiting participants yet, but it aims to gather valuable information about a potential new treatment option for managing focal epilepsy.

Gender

ALL

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