P De Liso1, F Vigevano2, N Specchio2, L De Palma2, P Bonanni3, E Osanni3, G Coppola4, P Parisi5, S Grosso6, A Verrotti7, A Spalice8, F Nicita8, N Zamponi9, S Siliquini9, L Giordano10, P Martelli10, R Guerrini11, A Rosati11, L Ilvento11, V Belcastro12, P Striano13, M S Vari13, G Capovilla14, F Beccaria14, O Bruni15, A Luchetti15, G Gobbi16, A Russo16, D Pruna17, A E Tozzi18, R Cusmai2. 1. Department of Neurosciences, Neurology Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy; Department of Paediatrics, Child Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy. Electronic address: Paola.deliso@opbg.net. 2. Department of Neurosciences, Neurology Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy. 3. Epilepsy and Clinical Neurophysiology Unit, Scientific Institute, IRCCS Eugenio Medea, Conegliano, Treviso, Italy. 4. Child and Adolescent Neuropsychiatry, Medical School, University of Salerno, Salerno, Italy. 5. NESMOS Department, Faculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University, Rome, Italy. 6. Paediatric Neurology-Immunology and Endocrinology Unit, University of Siena, Siena, Italy. 7. Department of Paediatrics, University of L'Aquila, L'Aquila, Italy. 8. Department of Paediatrics, Child Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy. 9. Child Neuropsychiatry Unit, Polytechnic University of the Marche, Ancona, Italy. 10. Paediatric Neuropsychiatric Division, Spedali Civili, Brescia, Italy. 11. Paediatric Neurology Unit, Children's Hospital A. Meyer, University of Firenze, Florence, Italy. 12. Neurology Unit, Department of Neuroscience, Sant'Anna Hospital, Como, Italy. 13. Paediatric Neurology and Muscular Diseases Unit, Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, G. Gaslini Institute, Genoa, Italy. 14. Department of Child Neuropsychiatry, Epilepsy Centre, C. Poma Hospital, Mantova, Italy. 15. Child Neuropsychiatry Unit, S. Andrea Hospital, Rome, Italy. 16. Child Neurology Unit, IRCCS Institute of Neurological Sciences, Bologna, Italy. 17. Epilepsy Unit, Child Neuropsychiatry Department, University Hospital, Cagliari, Italy. 18. Multifactorial and Complex Diseases Research Area, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
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 7.1mg (2-12mg). 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.
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 7.1mg (2-12mg). 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.
Authors: Song Ee Youn; Se Hee Kim; Ara Ko; Sun Ho Lee; Young Mock Lee; Hoon Chul Kang; Joon Soo Lee; Heung Dong Kim Journal: J Clin Neurol Date: 2018-07 Impact factor: 3.077