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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT03486366
Eligibility Criteria:
Inclusion Criteria WP1:
* male or female children with a definite diagnosis of TSC (Roach 1998),
* aged up to 4 years,
* diagnosis of epilepsy established on the basis of clinical seizures or
* epileptiform changes on EEG within 1-7 days prior to baseline ,
* written informed consent of caregivers.
Inclusion Criteria WP2:
* male or female children with a definite diagnosis of TSC (Roach criteria: Roach 1998) with epilepsy,
* aged up to 16 years,
* seizure free, in whom a decision to withdraw antiepileptic drugs was made,
* written informed consent of caregivers.
Exclusion Criteria:
\-
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
16 Years
Study:
NCT03486366
Study Brief:
Protocol Section:
NCT03486366