Efficacy, tolerability, and EEG lateralization-based predictors of neuropsychiatric adverse events in pediatric SeLECTS treated with perampanel monotherapy.

OBJECTIVE: To evaluate the long-term efficacy and safety of perampanel (PER) monotherapy in pediatric Self-limited Epilepsy with Centrotemporal Spikes (SeLECTS) and investigate the relationship between baseline EEG spatial characteristics and specific treatment-emergent adverse events (TEAEs).

STUDY DESIGN: This retrospective study included 62 treatment-naïve children newly diagnosed with SeLECTS receiving PER monotherapy. We assessed long-term seizure freedom rates, documented TEAEs, and evaluated the correlations between baseline EEG features and specific neuropsychiatric side effects.

RESULTS: At the final follow-up, 87.1% of patients achieved complete seizure freedom. Seizure persistence at 6 months strongly predicted a lower probability of achieving optimal long-term seizure control (p = 0.002). TEAEs occurred in 32.3% of patients (irritability 16.1%, somnolence 6.5%), with a 100% treatment retention rate. Notably, TEAE incidence was independent of PER dose (p = 0.582). Instead, predominantly left-hemispheric epileptic activity (OR=5.00, p = 0.039) and temporal lobe involvement (OR=10.02, p = 0.011) significantly predisposed patients to irritability. Conversely, predominantly right-hemispheric activity was significantly associated with an elevated risk of somnolence (OR=11.87, p = 0.0498).

CONCLUSION: PER monotherapy demonstrates robust efficacy and excellent tolerability in pediatric SeLECTS. Specific neuropsychiatric adverse events appear to be associated with hemisphere-dependent neurobiological factors, independent of dosage. Integrating baseline EEG lateralization profiles may inform future biomarker-guided approaches.