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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT01097720
Eligibility Criteria:
Inclusion Criteria:
* 36-83 months of age
* Prenatal exposure to LTG, VPA, or CBZ monotherapy
* AED was used by mother to suppress seizures
* Mother was enrolled in the North American AED Pregnancy Registry
Exclusion Criteria:
* Exposure during the first trimester to other known teratogens.
* Mother with mental health issues
* Refusal to release medical records to confirm eligibility.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
36 Months
Maximum Age:
83 Months
Study:
NCT01097720
Study Brief:
Protocol Section:
NCT01097720