Abstracts

Rationale: Sleep deprivation and daytime sleepiness may affect seizure control and QoL in patients with epilepsy but may also be caused by epilepsy itself. Furthermore, anti-seizure medications (ASMs) have been shown to affect sleep architecture. The AMPA Study (NCT04257604; Study 501) was a prospective, observational 12-month study to evaluate the effectiveness, safety, and QoL of adjunctive perampanel in routine clinical practice in Italy. Here, we present a post hoc analysis in a subgroup of patients (≥ 18 years) with excessive daytime sleepiness at baseline (Epworth Sleepiness Scale [ESS] score ≥ 11), stratified by the End-of-Study ESS score (< 11 [normal daytime sleepiness] vs. ≥ 11 [excessive daytime sleepiness])._x000D_ _x000D_ Methods: Patients with insufficiently controlled FOS, with/without focal to bilateral tonic-clonic seizures (FBTCS), while receiving 1 to 3 ASMs were prescribed adjunctive perampanel in line with the approved indication. The treating physician’s decision to prescribe perampanel was made before and independently of their decision to include the patient in the study. The primary endpoint was median percent change in seizure frequency per 28 days at 6 months (secondary endpoint, Month 12). Other secondary measures included 50% and 75% responder rates, seizure-freedom rates, ESS scores, QoL scores (assessed by the QoL in Epilepsy-31-Problems questionnaire [QOLIE-31-P]), and treatment-emergent adverse events (TEAEs). ESS scores of ≥ 11 are associated with excessive daytime sleepiness; therefore, we have used an ESS score of 11 as a threshold for analysis._x000D_ _x000D_ Results: Of the 234 patients who received adjunctive perampanel (Safety Analysis Set), 28 had a baseline ESS score ≥ 11 and were included in this analysis. Of those, 17 (60.7%) patients had a normal daytime sleepiness (ESS < 11) at the End of Study relative to baseline and 11 (39.3%) patients had an excessive daytime sleepiness (ESS ≥ 11). Median reduction from baseline in seizure frequency (last observation carried forward) at Months 6 and 12 was 70.5% (95% confidence interval, 27.3, 100.0) and 84.6% (58.8, 100.0) for patients with normal daytime sleepiness, and 44.8% (13.2, 81.8) and 46.8% (13.2, 89.0) for patients with excessive daytime sleepiness. Responder rates at Months 6 and 12 are presented in Figure 1. QOLIE-31-P scores are presented in Table 1; the mean change from baseline in the overall (total) QoL score was positive in patients with normal daytime sleepiness, indicating stable or improved health-related QoL, whereas the change in the overall (total) QoL score was negative in those with excessive daytime sleepiness. TEAEs were reported by 52.9% patients with a normal daytime sleepiness, and 72.7% patients with an excessive daytime sleepiness. _x000D_ _x000D_ Conclusions: In patients from Study 501 with excessive daytime sleepiness at baseline, the improvement in ESS score at the End of Study appears to correlate with improvements in seizure control, QoL, and tolerability. _x000D_ _x000D_ Funding: Eisai s.r.l.