Abstracts

Rationale: Several real-world studies on the use of perampanel have been published to date, but they had mainly a retrospective design. The present study has been designed as an observational, prospective study aimed at evaluating the effectiveness and safety profile of perampanel and its impact on quality of life; here we present the results of the ad interim analysis relative to the first 6 months of treatment. Methods: The study protocol was approved by the Technical Scientific Committee of the Italian Drug Agency and by the local Ethic’s Committees of the 19 participating centers. Patients > 12 years old with focal seizures prescribed perampanel according to the Summary of Product Characteristics were consecutively included. Study visits were scheduled at baseline and after 3, 6, and 12 months of treatment. Seizure diaries and adverse events were verified at each visit. QOLIE-31, Irritability in Epilepsy (I-Epi) and Epworth Sleepiness Scale questionnaires were administered to adult patients. The primary endpoint was the median percent change in seizure frequency from baseline to 6 months evaluated using the Wilcoxon matched-pairs signed-ranks; secondary endpoints included retention rate, responder rate, percentage of patients with adverse events, and change in the score of questionnaires. Results: 177 patients were included in the analysis (males=50.8%). Mean age was 37.4 years (range 12-84 ys). Mean age at diagnosis was 17.7 years. 48% of patients had symptomatic focal epilepsy. 36.7% of patients were affected by significant comorbidities. Perampanel was added to 1, 2, or >3 concomitant AEDs in 17.3%, 37.1%, and 45.6% of patients; 52% of patients had tried > 3 previous AEDs. Median dose of perampanel was 6 mg/day. At 6 months, the median reduction in seizure frequency vs. baseline was 73.8% (p<0.0001); 63% of patients were responders. Retention rates at 3 and 6 months were 97.4% and 72.4%, respectively. 46.9% of patients experienced at least one adverse event (mild or moderate in 94.6% of cases). 23 (13%) patients discontinued perampanel due to adverse events (median dose at discontinuation 4 mg/day). Most common adverse events were dizziness/vertigo and behavioral disturbances. Considering the median values at each time point, no relevant change of the score of questionnaires was detected. Conclusions: This ad interim analysis shows that perampanel is very effective in patients with focal seizures; no unexpected safety and tolerability issue emerged. As assessed through specific questionnaires, perampanel does not worsen daily somnolence and irritability and does not impair quality of life. Funding: The study has been supported by EISAI