Abstract
Objectives To assess perampanel (PER) in everyday clinical practice in paediatric patients.
Methods Paediatric patients treated with PER were identified from a pooled analysis of 44 global studies. Retention was assessed after 3, 6 and 12 months. Responder rate (≥50% seizure frequency reduction), seizure freedom rate (no seizures since at least prior visit) and adverse events (AEs) were evaluated. Data were analysed by age category.
Results 56 patients were identified (<4 years, n=5; 4–<7 years; n=12; 7–<12 years, n=39). Mean PER doses at baseline and last visit (last observation carried forward) were 1.8 and 2.3 mg/day; 1.8 and 4.1 mg/day; and 2.1 and 4.9 mg/day, in the three respective groups. Retention rates at 3, 6 and 12 months in patients aged <4 years were 50.0% at all timepoints; corresponding rates for patients aged 4–<7 and 7–<12 years were 90.0%, 70.0% and 0%, and 89.7%, 76.9% and 63.6%. At last visit, responder and seizure freedom rates in patients aged <4 years were 66.7% and 33.3%; corresponding rates for patients aged 4–<7 and 7–<12 years were 36.4% and 9.1%, and 58.3% and 27.8%. AEs were reported for 0%, 40.0% and 38.2% in the three groups. Most frequently reported were irritability (<4 years, 0%; 4–<7 years, 10%; 7–<12 years, 14.7%) and dizziness/vertigo (<4 years, 0%; 4–<7 years, 0%; 7–<12 years, 8.8%).
Conclusions PER was effective and generally well tolerated in this small population of paediatric patients treated in clinical practice.
Supported by Eisai
