Safety and tolerability of adjunctive brivaracetam in children with focal seizures: Interim analysis of pooled data from two open-label trials
作者: Anup D. PatelVincent BadalamentiTeresa GasallaSami ElmouftiJan-Peer Elshoff
作者单位: 1Nationwide Children's Hospital and The Ohio State University of Medicine, Columbus, OH, USA
2UCB Pharma, Raleigh, NC, USA
3UCB Pharma, Monheim am Rhein, Germany
刊名: European Journal of Paediatric Neurology, 2020, Vol.25 , pp.68-76
来源数据库: Elsevier Journal
DOI: 10.1016/j.ejpn.2019.11.007
关键词: PaediatricFocal seizureEpilepsy syndromeAntiepileptic drug
英文摘要: Abstract(#br)Objective(#br)To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy.(#br)Methods(#br)This was an interim analysis (cut-off March 15, 2017) of pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) was a 3-week trial of BRV 0.8–4 mg/kg/day in patients (1 month–<16 years) with epilepsy. Patients who completed this trial could continue into a long-term follow-up trial (N01266, NCT01364597) which also directly enrolled patients (4–<17 years) with focal seizures. After dose-escalation, patients received BRV 1–5 mg/kg/day (maximum 200 mg/day) during long-term evaluation. Data are reported for patients aged 4 to <16 years with focal seizures.(#br)Results(#br)The safety set comprised 149 patients: 34...
全文获取路径: Elsevier  (合作)
影响因子:1.982 (2012)

  • tolerability 可容许性
  • focal 焦点的
  • adjunctive 附属
  • label 标签标记
  • analysis 分析
  • children 子女