Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures.
J Child Neurol
; 26(10): 1271-83, 2011 Oct.
Article
em En
| MEDLINE
| ID: mdl-21673279
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Convulsões
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Frutose
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Anticonvulsivantes
Tipo de estudo:
Clinical_trials
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Observational_studies
Limite:
Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article