ELEVATE Study 410: Assessment of Cognition (EpiTrack®) Following Perampanel (Monotherapy/First Adjunctive) in Patients with Epilepsy and a History of Psychiatric/Behavioral Events
Vineet Punia1, Omar Samad2, Stella Ngo2, Dinesh Kumar2, Manoj Malhotra3
1Charles Shor Epilepsy Center, Cleveland Clinic, 2Eisai Inc., 3Formerly: Eisai Inc.
Objective:
To assess change from baseline in cognition (EpiTrack®) scores, efficacy, and safety in a subgroup of patients with a history of psychiatric and behavioral events from the Phase IV ELEVATE Study (Study 410; NCT03288129).
Background:
ELEVATE assessed perampanel monotherapy/first adjunctive therapy in patients aged ≥4 years with focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS).
Design/Methods:
The study consisted of Screening, Titration (≤13 weeks), Maintenance (39 weeks), and Follow-up (4 weeks) Periods. During Titration, patients received perampanel at 2 mg/day, which was up-titrated to 4 mg/day (further dose increases [of 2 mg] based on response and tolerability; maximum, 12 mg/day). The primary endpoint was retention rate at 3, 6, 9, and 12 months. Other endpoints included seizure freedom (Maintenance Period), median percent reduction in seizure frequency (Maintenance Period), cognition (assessed using EpiTrack® [patients ≥6 years of age; baseline, and 3 and 12 months]), and safety.
Results:
In the Safety Analysis Set, 54 patients received perampanel monotherapy/first adjunctive therapy. Of those, 24 patients (FOS, n=17; FBTCS, n=2; GTCS, n=4) had a history of psychiatric and behavioral events and were included in this post hoc analysis. The mean (standard deviation) changes from baseline in EpiTrack® total score at 12 months and end of treatment were -1.1 (3.14; n=11) and ‑0.5 (2.61; n=23), respectively (increase=improvement). Median percent reduction in seizure frequency/28 days during the entire Maintenance Period was 73.2% (n=22). The incidence of any treatment-emergent adverse events (TEAEs) in this subgroup was 95.8% (n=23/24). The most common TEAEs were dizziness (25.0%, n=6/24) and vomiting (20.8%, n=5/24).
Conclusions:
Perampanel as monotherapy/first adjunctive therapy was generally safe and efficacious in patients from ELEVATE with a history of psychiatric and behavioral events; EpiTrack® score in these patients was consistent with that observed in the overall patient population.