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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT04257604
Eligibility Criteria:
Inclusion Criteria:
1. Prescribe perampanel according to the approved indication
2. Participants with focal seizures with or without secondary generalization
3. Participants with seizure frequency data available at the baseline visit
4. Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel
5. The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study
6. Treatment with perampanel is not yet started before baseline
Exclusion Criteria:
1. Participants contraindicated for perampanel use (according to SmPC)
2. Participants with moderate to severe renal impairment
3. Participants with severe hepatic impairment
4. Pregnant or lactating women
5. Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04257604
Study Brief:
Protocol Section:
NCT04257604