Assess retention rate, safety, and dosing experience of perampanel administered to adolescent patients with epilepsy (aged 12 to <18 years) during routine clinical care. 

Perampanel is a once-daily oral antiepileptic drug for partial-onset seizures (POS) and primary generalized tonic-clonic seizures. We report second interim results for adolescent patients from the multicenter, non-interventional, Phase IV, retrospective Study 506 (NCT03208660).

The interim SAS (n=605 patients) included 101 patients aged 12 to <18 years (mean [standard deviation (SD)] age, 14.6 [1.8] years; female, 50.5%; mean [SD] age at epilepsy diagnosis, 5.7 [5.0] years; mean [SD] time since epilepsy diagnosis, 10.0 [5.0] years). Seizure types included: complex partial, n=51 (50.5%); POS with secondary generalization, n=31 (30.7%); and generalized tonic-clonic, n=46 (45.5%). The mean (SD) perampanel dose received was 5.7 (2.3) mg, and the mean (SD) maximum perampanel dose was 6.6 (3.4) mg. At data cut-off (March 5, 2018), 52 (51.5%) adolescent patients remained on perampanel and 49 (48.5%) had discontinued. Primary reasons for discontinuing included adverse event (AE; n=30 [29.7%]) and inadequate therapeutic effect (n=16 [15.8%]). Retention rates at 3, 6, 12, 18, and 24 months were 77.2% (n=78/101), 69.0 (n=69/100), 55.6% (n=50/90), 49.3% (n=35/71), and 52.9% (n=27/51), respectively. Treatment-emergent AEs were reported for 48.5% of patients; most common were aggression (8.9%), somnolence (7.9%), and irritability (5.9%). 

An interim subgroup analysis of the real-world Study 506 suggests daily oral doses of adjunctive perampanel are generally well tolerated, with favorable retention rates for ≤2 years in adolescent patients (12 to <18 years) with epilepsy.

Funding: Eisai Inc.