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 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT04398667
Eligibility Criteria:
Inclusion Criteria:
* Age ≥2 years
* Disease history of at least 24 months from date of first seizure
* Medical history of epilepsy associated with moderate to severe intellectual disability, cognitive developmental delay or cognitive regression
* Medical history of onset of seizures in early childhood (≤ 8 years)
* Failure of adequate trials of two tolerated and appropriately chosen and used Anti-Epileptic Drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom
* Ongoing refractory epilepsy
* MRI and EEG data are available for the participant
* Participants (or their parents/ legal representative as appropriate) have provided written informed consent / assent form to collect the data specified.
Exclusion Criteria:
* Normal cognitive development.
* Any acute symptomatic seizures in participants with underlying developmental delay.
* Any progressive intellectual and neurological deterioration conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT04398667
Study Brief:
Protocol Section:
NCT04398667