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:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01127256
Eligibility Criteria:
Inclusion criteria:
1. Epilepsy patients over 15 years old.
2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
4. Female who can be in the month of pregnancy should agree to prevent conception.
5. Patients who agree with Informed Consent Form.
Exclusion criteria:
1. Patients who have Myoclonic seizures and/or Absence seizures.
2. Patients who have progressive central nervous system (CNS) disorder.
3. Patients who have serious systemic disorder.
4. Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
5. Patients who have renal stones.
6. Medical history of medicinal poisoning and/or alcoholism.
7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT01127256
Study Brief:
Protocol Section:
NCT01127256