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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT02318602
Eligibility Criteria:
Inclusion Criteria:
* Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
* Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
* Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
* Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
* In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries
Exclusion Criteria:
* Inadequate supervision by parent(s)/caregiver(s)
* History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
3. the analysis of results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT02318602
Study Brief:
Protocol Section:
NCT02318602