Adjunctive Perampanel Oral Suspension in Pediatric Patients From ≥2 to <12 Years of Age With Epilepsy: Pharmacokinetics, Safety, Tolerability, and Efficacy.

Autor: Renfroe JB; 1 Child Neurology Center of Northwest Florida, Gulf Breeze, FL, USA., Mintz M; 2 The Center for Neurological and Neurodevelopmental Health (CNNH) and the Clinical Research Center of New Jersey (CRCNJ), Voorhees, NJ, USA., Davis R; 3 Pediatric Neurology, P.A., and Epilepsy Center of Central Florida, Orlando, FL, USA., Ferreira J; 4 Department of Pediatrics, University of South Florida, School of Medicine, Tampa, FL, USA.; 5 Pediatric Neurology, St. Joseph's Children's Hospital, Tampa, FL, USA.; 6 Pediatric Epilepsy and Neurology Specialists (PENS), Tampa, FL, USA., Dispoto S; 7 Eisai Neurology Business Group, Eisai Inc., Woodcliff Lake, NJ, USA., Ferry J; 8 Eisai Clinical Pharmacology, Eisai Inc., Woodcliff Lake, NJ, USA., Umetsu Y; 9 Eisai Co., Ltd., Tokyo, Japan., Rege B; 10 Formerly: Eisai Clinical Pharmacology, Eisai Inc., Woodcliff Lake, NJ, USA., Majid O; 11 Eisai Clinical Pharmacology, Eisai Ltd., European Knowledge Centre, Hatfield, Hertfordshire, United Kingdom., Hussein Z; 11 Eisai Clinical Pharmacology, Eisai Ltd., European Knowledge Centre, Hatfield, Hertfordshire, United Kingdom., Laurenza A; 12 Formerly: Eisai Neurology Business Group, Eisai Inc., Woodcliff Lake, NJ, USA.
Jazyk: angličtina
Zdroj: Journal of child neurology [J Child Neurol] 2019 Apr; Vol. 34 (5), pp. 284-294. Date of Electronic Publication: 2019 Feb 10.
DOI: 10.1177/0883073819827407
Abstrakt: Study 232, an open-label pilot study with an extension phase, evaluated the pharmacokinetics and preliminary safety/tolerability and efficacy of adjunctive perampanel oral suspension (≤0.18 mg/kg/d) in epilepsy patients aged ≥2 to <12 years. Patients were grouped into cohorts 1 (aged ≥7 to <12 years) and 2 (aged ≥2 to <7 years). The Core Study included pretreatment (≤2 weeks) and treatment phases (7-week titration; 4-week maintenance; 4-week follow-up [for those not entering the extension]). The extension phase consisted of 41-week maintenance and 4-week follow-up periods. Pharmacokinetic data were pooled with adolescent pharmacokinetic data from phase II/III studies. Population pharmacokinetic analysis showed that perampanel pharmacokinetics was independent of age, weight, or liver function, suggesting age- or weight-based dosing is not required and that the same dose can be given to adults and children to achieve exposures shown to be efficacious. Perampanel was well tolerated and efficacious for ≤52 weeks.
Databáze: MEDLINE