Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT04144218
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification criteria.
* Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.
* Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.
Exclusion Criteria:
* A history of status epilepticus within 3 months prior to screening visits.
* Poor adherence to previous treatment.
* Other serious organic diseases, mental illnesses and neurological diseases.
* Abnormal liver and kidney function and blood routine results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT04144218
Study Brief:
Protocol Section:
NCT04144218