Abstract
Background Anti-seizure medication may affect sleep and quality of life (QoL), impacting health and daily activities of patients with epilepsy. The prospective, observational, Phase IV Study 512 (NCT04252846) assessed first adjunctive perampanel in patients (≥12 years) with focal or generalised epilepsy. This Study 512 analysis assessed the effects of perampanel on seizure freedom, daytime sleepiness and QoL.
Methods Patients were administered 2–12 mg/day of perampanel and observed for ≤12 months after treatment initiation. Endpoints included completer (proportion of patients receiving perampanel at 12 months who were seizure free) and pragmatic seizure-freedom rates (proportion of seizure-free patients in the Full Analysis Set [FAS]); daytime sleepiness (Epworth Sleepiness Scale [ESS]) and QoL (QoL in Epilepsy Inventory 10 [QOLIE-10]) changes in adults (≥18 years), and safety were assessed in the Safety Analysis Set (SAS).
Results The SAS and FAS included 182 and 174 patients, respectively; median age was 36 years. At 12 months, 63 patients achieved completer (46.7%) and pragmatic (36.2%) seizure freedom. A shift in daytime sleepiness from normal (ESS score ≤10) to excessive sleepiness (ESS score >10) was reported in two patients at 12 months, whereas two patients reported a shift from excessive to normal sleepiness. There was a mean (standard deviation) change from baseline in QOLIE-10 total score of -0.5 (0.9 [n=8]) at 12 months. Common treatment-emergent adverse events were dizziness (10.4%) and irritability (8.8%).
Conclusions First adjunctive perampanel demonstrated promising seizure-freedom rates; daytime sleepiness and QoL scores did not worsen with treatment. No new safety signals were identified.
