Abstract
Objectives Here, we present the interim safety data from Study 238 (NCT02914314), an ongoing Phase II, multicentre, open-label study of adjunctive perampanel oral suspension in patients aged ≥1 to <24 months with a diagnosis of epilepsy with any type of seizure.
Methods The Core Study comprises Pretreatment (≤2 weeks) and Treatment Phases (12–16-week Titration; 4-week Maintenance) and a Follow-up Period (4 weeks; for patients not entering the Extension). The Extension Phase comprises 32–36-week Maintenance and 4-week Follow-up Periods. Perampanel is initiated at 0.5 mg/day and titrated to a maximum of 12 mg/day (patients taking non-enzyme-inducing anti-seizure medications [EIASMs]) or 16 mg/day (patients taking EIASMs) based on clinical response and tolerability. Safety endpoints during the Core Study: incidence of TEAEs, TEAEs of interest and serious TEAEs.
Results As of December 29, 2020, 15 patients (mean [standard deviation (SD)] age, 14.7 [6.1] months) initiated perampanel treatment (mean [SD] daily dose, 5.2 [2.7] mg) in the Core Study; 12/15 patients continued into the Extension. TEAEs occurred in 15 (100.0%) patients; 11 (73.3%) patients reported treatment-related TEAEs. No TEAEs led to treatment discontinuation. Overall, 17 TEAEs of interest were reported; the most common was somnolence (n=4). Six (40.0%) patients (aged 5–23 months) reported serious TEAEs (all unrelated to perampanel); no deaths occurred and all patients recovered from their TEAEs without any dose adjustments.
Conclusions These interim data suggest perampanel is generally well tolerated in paediatric patients aged ≥1 to <24 months with epilepsy; no unexpected safety signals emerged.
Funding Eisai Inc.
