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Abstract Details

Assessment of Cognition (EpiTrack®) and Depression (Beck Depression Inventory-II) Following Perampanel (Monotherapy/First Adjunctive) in Patients with Epilepsy Enrolled in The ELEVATE Phase IV Study
Epilepsy/Clinical Neurophysiology (EEG)
P1 - Poster Session 1 (9:00 AM-5:00 PM)
152
Using interim data from ELEVATE (NCT03288129), we present change from baseline in cognition (EpiTrack®) and depression scores (Beck Depression Inventory-II [BDI-II]) by seizure type at 12 months.
ELEVATE was a 12-month, open-label, Phase IV study of perampanel administered as monotherapy or first adjunctive therapy to patients aged ≥4 years with focal-onset seizures (FOS) or generalized tonic-clonic seizures (GTCS).
ELEVATE consisted of Screening, Titration (≤13 weeks), Maintenance (39 weeks), and Follow-up (4 weeks) Periods. During Titration, patients initiated perampanel at 2 mg/day then titrated to 4 mg/day or higher (maximum: 12 mg/day). Dose increases were ≥2 weeks apart for patients taking a non-enzyme-inducing anti-seizure medication (EIASM) and weekly for those taking EIASMs. Cognition (EpiTrack®) and depression (BDI-II) were assessed at baseline, and at 3 and 12 months.

As of March 23, 2021, 23 patients with FOS (n=16) or GTCS (n=7) were included in the Safety Analysis Set; 12 completed; 11 discontinued. Mean (standard deviation [SD]) change from baseline in EpiTrack® total score was -1.4 (4.0) for FOS (n=9) and +1.3 (1.2) for GTCS (n=3) patients (12 months; increase = improvement). Two patients with FOS had an improved shift and two a worsening shift from their baseline EpiTrack® category (12 months). No shifts for patients with GTCS were observed. Mean (SD) change from baseline in BDI-II total score was +0.7 (8.5) for FOS patients and +4.0 (9.6) for GTCS patients (12 months; increase = worsening). One FOS patient had an improved shift, and two patients a worsening shift (1 with FOS and 1 with GTCS), from their baseline BDI-II mood category (12 months).
Perampanel did not affect cognition with some patients reporting improvement at 12 months relative to baseline. Overall, there was no clinically relevant worsening of depression. Additional analyses will be included in the presentation.
Authors/Disclosures
Joon Y. Kang, MD (Thomas Jefferson University)
PRESENTER 		Dr. Kang has nothing to disclose.
Omar Samad, PhD (Mallinckrodt Pharmaceuticals) Dr. Samad has received personal compensation for serving as an employee of Eisai.
Dinesh Kumar Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
Stella L. Ngo, PhD Dr. Ngo has received personal compensation for serving as an employee of Neurelis Inc.. Dr. Ngo has received personal compensation for serving as an employee of Neurelis Inc..
Manoj Malhotra, MD Dr. Malhotra has received personal compensation for serving as an employee of Eisai.