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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02968966
Eligibility Criteria:
Inclusion Criteria:
* highly active epilepsy (≥ 1 seizure per day)
* epilepsy with onset 0-3 months of age
* pharmaco-resistant epilepsy (2 or more standard anticonvulsive medications tried before)
* recently max. two stable anticonvulsive drugs for minimum 4 days before study start
* patients under continuous monitoring control
* patients younger than 1 year of age
Exclusion Criteria:
* high grade cardial rhythm disorders
* severe liver, renal and electrolyte blood parameter changes
* metabolic or lesional origin of epilepsy (metabolic screening results and cranial MRI available)
* parallel participation in other studies (must be finished two month before study start)
* missing informed consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Months
Study:
NCT02968966
Study Brief:
Protocol Section:
NCT02968966