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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05867160
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients of any ethnic origin ≥18 years old at baseline.
* Patients with diagnosis of focal-onset seizures with or without secondary generalization.
* Patients should have been eligible to start treatment with ASM as adjunctive therapy according to the physician's judgement prior to the inclusion.
* Patients should have clinical history of treatment failure with at least 2 ASMs.
* Patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members).
* Written informed consent (including data privacy consent) signed by the patient, legal guardian, or legally authorized representative prior to entering the study in accordance with the ICH GCP guidelines
Exclusion Criteria:
* Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
* Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
* Patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the Investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania).
* Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator could affect the participant's safety or interfere with study assessments.
* Patients with substance abuse or dependence (except for caffeine and nicotine).
* Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05867160
Study Brief:
Protocol Section:
NCT05867160