| Long-Term Open-Label Study of Adjunctive Topiramate in Infants With Refractory Partial-Onset Seizures. | |
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MedLine Citation:
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PMID: 21673279 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: JOURNAL ARTICLE Date: 2011-6-14 |
Journal Detail:
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Title: Journal of child neurology Volume: - ISSN: 1708-8283 ISO Abbreviation: - Publication Date: 2011 Jun |
Date Detail:
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Created Date: 2011-6-15 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8606714 Medline TA: J Child Neurol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Kentucky Neuroscience Research, Louisville, Kentucky. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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