2013
DOI: 10.1111/epi.12233
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A randomized phase III trial of adjunctive zonisamide in pediatric patients with partial epilepsy

Abstract: SUMMARYPurpose: To assess the efficacy and safety/tolerability of adjunctive zonisamide treatment in pediatric patients with partial epilepsy. Methods: In this phase III, double-blind, randomized, placebo-controlled, multicenter trial, 207 patients (age 6-17 years) with partial epilepsy, receiving one or two antiepileptic drugs, were randomized to receive adjunctive zonisamide or placebo. Zonisamide was initiated at 1 mg/kg/day, titrated to a target dose of 8 mg/kg/day over 8 weeks (one down-titration permitte… Show more

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Cited by 52 publications
(70 citation statements)
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“…[19][20][21][22][23][24][25][26][27][28] The Duchowny study 21 was excluded from the network, as seizure reduction outcome was missing. [19][20][21][22][23][24][25][26][27][28] The Duchowny study 21 was excluded from the network, as seizure reduction outcome was missing.…”
Section: Refractory Focal Epilepsymentioning
confidence: 99%
“…[19][20][21][22][23][24][25][26][27][28] The Duchowny study 21 was excluded from the network, as seizure reduction outcome was missing. [19][20][21][22][23][24][25][26][27][28] The Duchowny study 21 was excluded from the network, as seizure reduction outcome was missing.…”
Section: Refractory Focal Epilepsymentioning
confidence: 99%
“…Full details of the design of the Phase III trial and extension study, including the inclusion/ exclusion criteria employed, have been published previously (5,6). In the initial trial, children with partial epilepsy, receiving one or two AEDs, were randomized to receive adjunctive zonisamide or placebo.…”
Section: Methodsmentioning
confidence: 99%
“…Zonisamide is licensed in Europe and the USA for the adjunctive treatment of partial seizures (with or without secondary generalization) in adults (3,4). Approval for pediatric use was based on the results of a Phase III, double-blind, randomized, placebo-controlled, multicenter trial (5). Approval for pediatric use was based on the results of a Phase III, double-blind, randomized, placebo-controlled, multicenter trial (5).…”
Section: Introductionmentioning
confidence: 99%
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