Document Detail


Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures.
MedLine Citation:
PMID:  21673279     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Vinay Puri; Seth Ness; Sita Jayalakshmi Sattaluri; Steven Wang; Mike Todd; Eric Yuen; Marielle Eerdekens; Jeffrey S Nye; Prasarn Manitpisitkul; Kevin Shalayda; Lisa Ford
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-06-14
Journal Detail:
Title:  Journal of child neurology     Volume:  26     ISSN:  1708-8283     ISO Abbreviation:  J. Child Neurol.     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-10-11     Completed Date:  2012-02-08     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  8606714     Medline TA:  J Child Neurol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1271-83     Citation Subset:  IM    
Affiliation:
Kentucky Neuroscience Research, Louisville, Kentucky, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00113815;  NCT00233012
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MeSH Terms
Descriptor/Qualifier:
Anticonvulsants / therapeutic use*
Child, Preschool
Dose-Response Relationship, Drug
Double-Blind Method
Female
Fructose / analogs & derivatives*,  therapeutic use
Humans
Infant
Longitudinal Studies
Male
Seizures / drug therapy*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticonvulsants; 0H73WJJ391/topiramate; 30237-26-4/Fructose

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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