PROLEVIS
(2025)Objective
To evaluate whether prophylactic levetiracetam reduces clinical seizures within one year of stroke onset
Study Summary
• Prophylactic levetiracetam did not reduce seizures at 1 year vs placebo
• Most seizures occurred early (<3 months) with no between-group difference
• No differences in functional outcomes, mortality, or stroke recurrence
• Most seizures occurred early (<3 months) with no between-group difference
• No differences in functional outcomes, mortality, or stroke recurrence
Intervention
Levetiracetam (250mg BID × 1 week, then 500–750mg BID based on weight × 3 months) vs placebo
Inclusion Criteria
Post-stroke patients within 14 days of stroke onset
Study Design
Arms: Levetiracetam + standard care vs Placebo + standard care
Patients per Arm: 215 levetiracetam, 215 placebo (mITT population)
Outcome
• Primary: Clinical seizure within 1 year — no significant difference
• Early vs late seizures: No difference between groups
• Functional outcomes (mRS 3 and 12 months): No difference
• Mortality at 3 and 12 months: No difference
• AEs: Slight increase in CNS symptoms with levetiracetam
• Early vs late seizures: No difference between groups
• Functional outcomes (mRS 3 and 12 months): No difference
• Mortality at 3 and 12 months: No difference
• AEs: Slight increase in CNS symptoms with levetiracetam