Abstracts

Rationale: In the US and Europe, perampanel is approved for focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), in patients aged ≥ 4 years (US: monotherapy/adjunctive; Europe, adjunctive), and generalized tonic-clonic seizures in patients aged ≥ 12 (≥ 7, Europe) years (adjunctive). The AMPA Study (NCT04257604; Study 501) was a prospective, observational 12-month study to evaluate the effectiveness and safety of adjunctive perampanel and its impact on QoL and sleep in routine clinical practice in Italy. Here, we present final QoL and sleep outcomes from the AMPA Study.

Methods: Adult and adolescent patients (aged ≥ 12 years) with insufficiently controlled FOS, with/without FBTCS, while receiving 1–3 anti-seizure medications 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. QoL was assessed by the QoL in Epilepsy-31-Problems (QOLIE-31-P) questionnaire and sleepiness was assessed by the Epworth Sleepiness Scale (ESS) in adult patients (aged ≥ 18 years) from the Safety Analysis Set at baseline and end of treatment (up to 12 months; last observation carried forward [LOCF]). A high score on the QOLIE-31-P reflects good QoL; a high score on the ESS indicates greater sleepiness (ESS scored between 0–24).

Results: Overall, 234 patients received adjunctive perampanel (Safety Analysis Set), of which 208 (88.9%) patients were adults. At baseline and at the end of treatment (LOCF), the mean (standard deviation [SD]) overall QoL score, which is determined based on responses to the seven QOLIE-31-P domains, was similar: 56.0 (16.1) (n=203) and 57.7 (18.3) (n=160), respectively (mean [SD] change from baseline: 1.2 [14.2], n=157). Across all individual QOLIE-31-P domains, scores at baseline and at the end of treatment remained similar (Table 1); seizure worry showed the biggest improvement at the end of treatment vs baseline (mean [SD] change: 7.1 [25.0]), followed by medication effects (mean [SD] change: 3.6 [32.8]). The domains of emotional wellbeing (mean [SD] change: -1.7 [20.5]) and overall QoL (mean [SD] change: -1.8 [19.8]) were the only two domains to have a slightly lower score at the end of treatment vs baseline; however, these differences are not deemed clinically important and as noted above, the overall QoL score was similar at end of treatment vs baseline. Based on 202 adult patients, the mean (SD) ESS score at baseline was 6.3 (4.5). At the end of treatment, the mean (SD) ESS score was 6.2 (4.4; n=177; LOCF), which was similar to the baseline score (mean [SD] change: 0 [4.7], n=174).

Conclusions: Overall, these data suggest that adjunctive perampanel does not negatively affect QoL or sleep following up to 12 months of treatment in adult patients with FOS, with or without FBTCS.

Funding: Please list any funding that was received in support of this abstract.: Eisai s.r.l.