Abstracts

Rationale: Perampanel is a once-daily oral anti-seizure drug (ASD) for partial-onset seizures and primary generalized tonic-clonic seizures (PGTCS). Information from prospective clinical studies on perampanel as monotherapy or early adjunctive therapy is limited since Phase III registration studies evaluated perampanel as adjunctive therapy in treatment-resistant patients (pts). The ELEVATE study (Study 410; NCT03288129) is a 12-month, multicenter, open-label, Phase IV study (Figure 1), and is the first prospective study of perampanel administered as monotherapy or first adjunctive therapy in pts aged >=12 years with partial-onset seizures, with or without secondarily generalized seizures (SGS), or PGTCS. Here, we provide an update on the enrollment status of ELEVATE. Methods: Approximately 125 pts are planned for enrollment at 25 sites in the US. During Titration, perampanel 2 mg/day will be taken and uptitrated to 4 mg/day based on clinical response and tolerability; pts can receive <=12 mg/day depending on their need for additional efficacy (titration: 2-mg/day increments at a minimum of 2-week intervals). Pts receiving enzyme-inducing ASDs can be uptitrated in 2-mg/day increments at 1-week intervals. Primary endpoint is retention rate at 3, 6, 9, and 12 months. Secondary endpoints include safety and seizure freedom. Baseline seizure counts will be collected retrospectively and prospectively for the 12-week period prior to first dose, and seizure diaries will be used to collect seizure counts during the study. Results: Twenty-five sites have been confirmed in the US; 24 are actively recruiting pts. As of May 8, 2019, 33 pts have been screened for entry into the study (first patient in August 2017) and 29 have received perampanel. It is projected that the last pt will be enrolled into the study on March 31, 2020. Conclusions: ELEVATE will provide an overview of retention rates, and efficacy and safety data for perampanel as monotherapy or first adjunctive therapy in pts (aged >