Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study

Korábbi kezelés

• 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).
• Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.

Más betegség

• Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
• 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.

Egyéb

• Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
• Patients with substance abuse or dependence (except for caffeine and nicotine).

• 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