Study assessments
ideation, seizures, seizure, stroke, Deaths
ADVERSE EVENTS, STROKE
The primary efficacy endpoint is the proportion of patients experiencing a first unprovoked seizure within the first 6 months after randomization (“failure rate”). Deaths before month 6 after randomization or patients without evaluable assessment of the primary endpoint will be counted as treatment failures. Secondary efficacy assessments comprise: the proportion of patients who experience a first unprovoked seizure during the first 12 months after randomization (“12‐month failure rate”); the proportion of patients who experience a first unprovoked seizure during the course of the study (i.e., until 18 months after randomization; “18‐month failure rate”); the number of acute symptomatic seizures; time to first unprovoked seizure after randomization; time to first unprovoked seizure after stroke occurrence; the number and 4‐week rate of unprovoked seizures; functional outcomes, assessed using the Barthel Index original 10‐item versionSafety assessments include the evaluation of: treatment‐emergent adverse events, including findings from physical and neurological examinations; laboratory parameters (hematology, biochemistry, estimated glomerular filtration rate, coagulation, and urinalysis); vital signs; electrocardiogram; and suicidal ideation and behavior (assessed using question 9 of the PHQ‐9).