Epilepsy
Conditions
Interventions
single arm:zonisamide Oral administration, once or twice daily. Titration period: the initial dose was 100 mg/maintenance dose was 200-400 mg/day, increased by 100 mg/day every 2 weeks, 8 to achieve t
Sponsors
QiLu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who agreed to participate in the clinical trial, and the subject and/or legal guardian has signed protocol informed consent; 2. Male and female patients aged 18-75 years; 3. Focal epilepsy or focal to bilateral tonic clonic seizures diagnosed?by?criteria in seizures classification developed by the International League Against Epilepsy (ILAE) in 2017; 4. Patients who had taken one antiepileptic drug in the past four weeks and the researcher agreed?that they were suitable with zonisamide add-on treatment; 5. During the 8-week retrospective baseline period, patients must have had at least 2 focal to bilateral tonic clonic seizures per 28 days on average.
Exclusion criteria
Exclusion criteria: 1. Patients had received previous Zonisamide treatment; 2. Female patients are pregnant, breast-feeding, and will not use contraception during the trial; 3. Patients had known allergies to sulfonamides or any ingredients in Zonisamide; 4. history of drug/alcohol abuse; 5. Current use of Antidepressants, anxiolytics or antipsychotics; 6. History of suicide attempt or suicidal ideation in the past 6 months; 7. Patients suffer from progressive diseases that affect the patient's brain and its function; 8. Sychogenic nonepileptic seizures; 9. Patients suffer from serious lung and blood system diseases, malignant tumor, lower immune function and psychosis; 10. Patients Had epilepsy brain surgery, or will undergo epilepsy surgery in the next four months. 11. Investigators considered Patients as unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In patients with focal epilepsy with or without secondary bilateral tonic clonic seizures, The change in seizure frequency per 4 week from retrospective baseline to the maintenance period;In patients with focal epilepsy with or without secondary bilateral tonic clonic seizures,The percentage of subjects with a 50 % or greater reduction in seizure frequency per 4 weeks from retrospective baseline to maintenance; | — |
Secondary
| Measure | Time frame |
|---|---|
| In patients with focal epilepsy with or without secondary bilateral tonic clonic seizures, percentage of subjects who achieved seizure-free during maintenance period;Evaluation for depression status;Evaluation for anxiety status;Evaluation for Cognitive function;Retention rate; | — |
Countries
China
Contacts
Public ContactLiu Xuewu
Qilu Hospital of Shandong University
Outcome results
None listed