Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies—An Italian observational multicenter study

Paola De Liso, Federico Vigevano, Nicola Specchio, Luca De Palma, Paolo Bonanni, E. Osanni, Giangennaro Coppola, P. Parisi, Salvatore Grosso, Alberto Verrotti, A. Spalice, Francesco Nicita, Nelia Zamponi, Sabrina Siliquini, Lucio Giordano, P. Martelli, Renzo Guerrini, Anna Rosati, Lucrezia Ilvento, Vincenzo BelcastroPasquale Striano, M. S. Vari, Giuseppe Capovilla, F. Beccari, Oliviero Bruni, Anna Luchetti, Giuseppe Gobbi, Angelo Russo, D. Pruna, Alberto Eugenio Tozzi, Raffaella Cusmai

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose To evaluate the efficacy and tolerability of Perampanel (PER) in children and adolescents with refractory epilepsies in daily clinical practice conditions. Patients and methods This Italian multicenter retrospective observational study was performed in 16 paediatric epilepsy centres. Inclusion criteria were: (i) ≤18 years of age, (ii) history of refractory epilepsy, (iii) a follow-up ≥5 months of PER add-on therapy. Exclusion criteria were: (i) a diagnosis of primary idiopathic generalized epilepsy, (ii) variation of concomitant AEDs during the previous 4 weeks. Response was defined as a ≥50% reduction in monthly seizure frequency compared with the baseline. Results 62 patients suffering from various refractory epilepsies were included in this study: 53% were males, the mean age was 14.2 years (range 6–18 years), 8 patients aged <12 years. Mean age at epilepsy onset was 3.4 years and the mean duration of epilepsy was 10.8 years (range 1–16), which ranged from 2 seizures per-month up to several seizures per-day (mean number = 96.5). Symptomatic focal epilepsy was reported in 62.9% of cases. Mean number of AEDs used in the past was 7.1; mean number of concomitant AEDs was 2.48, with carbamazepine used in 43.5% of patients. Mean PER daily dose was 7.1 mg (2–12 mg). After an average of 6.6 months of follow-up (5–13 months), the retention rate was 77.4% (48/62). The response rate was 50%; 16% of patients achieved ≥75% seizure frequency reduction and 5% became completely seizure free. Seizure aggravation was observed in 9.7% of patients. Adverse events were reported in 19 patients (30.6%) and led to PER discontinuation in 4 patients (6.5%). The most common adverse events were behaviour disturbance (irritability and aggressiveness), dizziness, sedation and fatigue. Conclusion PER was found to be a safe and effective treatment when used as adjunctive therapy in paediatric patients with uncontrolled epilepsy.

Original languageEnglish
Pages (from-to)93-100
Number of pages8
JournalEpilepsy Research
Volume127
DOIs
Publication statusPublished - Nov 1 2016

Keywords

  • Adolescents
  • Antiepileptic drug
  • Children
  • Perampanel
  • Refractory epilepsy
  • Treatment outcome

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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