Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study - Arzimanoglou, Alexis; Ferreira, Jose A.; Satlin, Andrew; Mendes, Shannon; Williams, Betsy; Critchley, David; Schuck, Edgar; Hussein, Ziad; Kumar, Dinesh; Dhadda, Shobha; Bibbiani, Francesco (European journal of paediatric neurology, 2016)
Keywords: Anticonvulsants - adverse effects; Anticonvulsants - pharmacokinetics; Antiepileptic drug therapy; Child, Preschool; Female; Humans; Infant; Infants; Lennox Gastaut Syndrome - drug therapy; Lennox-Gastaut syndrome; Male; Neurology; Pediatrics; Pharmacokinetic; Randomized study; Rufinamide; safety; Triazoles - adverse effects; Triazoles - pharmacokinetics; AED; Rufinamide; Antiepileptic drug therapy; MedDRA; CI; EEG; CRCL; ECG; Infants; Pharmacokinetic; AUC; SD; Lennox-Gastaut syndrome; TEAE; safety; SAE; IIV; Cav; LGS; Randomized study; PK; CL/F; antiepileptic drug; steady-state exposure; interindividual variability; treatment-emergent adverse event; Medical Dictionary for Regulatory Activities; electrocardiogram; serious adverse event; creatinine clearance; C av; electroencephalogram; area under the concentration–time curve; confidence interval; apparent clearance; standard deviation