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 @ 12:30 PM
Ignite Modification Date:
2025-12-24 @ 12:30 PM
NCT ID:
NCT02021461
Eligibility Criteria:
Inclusion Criteria:
* A written informed consent form signed by the subject's parent(s) or guardian(s) and an assent form for any 7-year-old subjects signed by subjects.
* Male or female, between the age of 5 to \<8 years.
* Diagnosed with partial-onset epilepsy.
* Is considered, in the opinion of the investigator, to be able to make the required taste assessment.
Exclusion Criteria:
* Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorder.
* Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
* Strong congestion, flu, or any other acute illness that could influence the child's sense of taste.
* A known swallowing or taste perception problem.
* Currently or previously treated with ESL.
* Concomitant participation in another drug clinical trial.
* Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
8 Years
Study:
NCT02021461
Study Brief:
Protocol Section:
NCT02021461