Dataset from Pharmacokinetics of Diazepam in Children with Status Epilepticus

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).