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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT04166305
Eligibility Criteria:
Inclusion Criteria:
* Patient with diagnosis of epilepsy (idiopathic or cryptogenic/symptomatic), according to the International League Against Epilepsy classification confirmed by electroencephalogram.
* Treatment with at least one AED, long enough to achieve the optimal dose; drug-resistance and drug-responsiveness, according to the criteria ILAE 2010.
Exclusion Criteria:
* Patient with severe adverse anti-epileptic drug reactions.
* Patient with unreliable records of seizure frequency.
* Patient with poor compliance with AEDs,.
* Patient with significant psychiatric comorbidity,
* Patient with progressive systemic disorders .
* Patient with history of alcohol or drug abuse.
* Epileptic patients in clinical remission or with gradual withdrawal of therapy.
* Epileptic patients with therapy titration phase.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT04166305
Study Brief:
Protocol Section:
NCT04166305