title: Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures.
abstract: Data from 2 studies (phase 1 and phase 3) in infants <2 years old (N = 284; mean [SD] age, 12[6.3] months) with refractory partial-onset seizures were pooled to assess the long-term safety up to 1 year (primary objective) and tolerability of adjunctive topiramate treatment (mean treatment duration = 282 days). Monthly seizure rate summaries were also assessed. During the open-label extensions of these studies, study medication was first titrated to a dose of 25 mg/kg/d with subsequent uptitration to the maximum dosage tolerated, or seizure freedom, or a maximum of 60 mg/kg/d, whichever occurred first. The most common treatment-emergent adverse events (≥30%) were fever (52%), respiratory tract infections (51%), anorexia (35%), and acidosis (31%). Mean (SD) changes from pretreatment baseline to endpoint in Z scores for growth parameters were as follows: -0.82 (1.19) (body weight), -0.45 (1.60) (body length), and -0.36 (1.02) (head circumference).Tolerability in infants was consistent with previous studies.
authors.affiliation: Kentucky Neuroscience Research, Louisville, Kentucky, USA.
authors.forename: Vinay
authors.initials: V
authors.lastname: Puri
authors.forename: Seth
authors.initials: S
authors.lastname: Ness
authors.forename: Sita Jayalakshmi
authors.initials: SJ
authors.lastname: Sattaluri
authors.forename: Steven
authors.initials: S
authors.lastname: Wang
authors.forename: Mike
authors.initials: M
authors.lastname: Todd
authors.forename: Eric
authors.initials: E
authors.lastname: Yuen
authors.forename: Marielle
authors.initials: M
authors.lastname: Eerdekens
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Nye
authors.forename: Prasarn
authors.initials: P
authors.lastname: Manitpisitkul
authors.forename: Kevin
authors.initials: K
authors.lastname: Shalayda
authors.forename: Lisa
authors.initials: L
authors.lastname: Ford
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use*; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008137:Longitudinal Studies; D008297:Male; D012640:Seizures / Q000188:drug therapy*; D000077236:Topiramate; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose