Document Detail


Adaptive behavior outcomes in infants treated with adjunctive topiramate.
MedLine Citation:
PMID:  22633629     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Data from two global studies (6-week open-label, phase 1 study; 20-day double-blind, phase 3 study) and their 1-year open-label extensions were pooled to assess long-term effects of adjunctive topiramate on adaptive behavior in infants with clinical or video-electroencephalographic evidence of refractory, partial-onset seizures. The primary safety and efficacy results of adjunctive topiramate treatment were reported previously. We report the changes in adaptive behavior of infants, based on Vineland Scales of Adaptive Behavior. Of 284 infants (mean [S.D.] age, 12 [6.3] months) enrolled, 89% (n = 252) manifested partial-onset seizures, and 41% (n = 116) manifested clinically relevant, symptomatic etiologies at pretreatment baseline. Overall, Vineland scores were below average at pretreatment baseline. The most frequently used concomitant antiepileptic drugs included valproic acid (59%), phenobarbital (31%), and carbamazepine (19%). The most common treatment-emergent cognitive and neuropsychiatric adverse events included anorexia (35%) and somnolence (27%). A clinically significant decline (approximately 15 points, or 1 S.D.) occurred in both Vineland Scales composite (mean change, -14.0) and domain standard scores from pretreatment baseline to open-label extension endpoint. However, individual domain raw scores increased, indicating that infants progressed in acquisitions of adaptive skill, but at a slower rate than the normative population.
Authors:
Seth Ness; Mike J Todd; Steven Wang; Marielle Eerdekens; Jeffrey S Nye; Lisa Ford
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatric neurology     Volume:  46     ISSN:  1873-5150     ISO Abbreviation:  Pediatr. Neurol.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-28     Completed Date:  2013-03-29     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  8508183     Medline TA:  Pediatr Neurol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  350-8     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
Affiliation:
Janssen Research and Development, LLC, Raritan, New Jersey, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00113815;  NCT00233012
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MeSH Terms
Descriptor/Qualifier:
Adaptation, Psychological / drug effects*,  physiology
Anticonvulsants / administration & dosage*
Child, Preschool
Double-Blind Method
Drug Therapy, Combination
Female
Fructose / administration & dosage,  analogs & derivatives*
Humans
Infant
Infant Behavior / drug effects*,  physiology,  psychology
Infant, Newborn
Male
Seizures / drug therapy*,  psychology
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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