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 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT00292461
Eligibility Criteria:
Inclusion criteria:
* Subjects must sign and date the informed consent form
* Clinical diagnosis as refractory epilepsy
Exclusion criteria:
* Progressive neurologic disease
* Serious psychiatric disease
* Hemolytic anemia
* G6PD (glucose-6-phosphate dehydrogenase) deficiency
* Acute intermittent porphyrias
* Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past
* Drug or alcohol addiction
* Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST \> 2x ULN)
* Stevens-Johnson syndrome
* Progressive exfoliative dermatitis
* Pregnant, lactating or of childbearing potential female
* Regularly taking oral contraceptives
* Hypersensitivity to study drugs
* Severe cardiac disease (New York Heart Association Functional Class III and IV)
* History of malignancy within 5 years
* Taking valproic acid within 7 days prior to screening
* Subjects with simple partial seizures without motor component
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT00292461
Study Brief:
Protocol Section:
NCT00292461