Model Development Dataset in Pharmacokinetics of Diazepam in Children with Status Epilepticus

Model Development Dataset
Study Description
Analysis of diazepam data and pharmacokinetic (PK) samples obtained from the NICHD-2003-10-2 (BPCA Status 2) study, a double-blinded, randomized, controlled trial comparing efficacy and short-term safety of lorazepam versus diazepam in pediatric status epilepticus (SE). The primary objective of the NICHD-2015-DZP01 (BPCA DZP01) study was to determine the PK of diazepam for pediatric SE using sparse sampling. The secondary objective was to determine the safety and efficacy of diazepam for pediatric SE. The Status 2 and DZP01 studies were both conducted under the Best Pharmaceuticals for Children Act (BPCA). The DPZ01 study included data from children ages 3 months to less than 18 years with status epilepticus who were randomized to diazepam in previous study (NICHD-2003-10-2 - BPCA Status 2). See https://dash.nichd.nih.gov/study/18573.