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Safety and Tolerability of Adjunctive Brivaracetam in Pediatric Patients?

ABSTRACT: OBJECTIVE:This trial evaluated the short-term safety and tolerability, steady-state pharmacokinetics, and preliminary efficacy of brivaracetam oral solution in children aged 1 month to?

SUBMITTER: Liu E 

PROVIDER: S-EPMC6682562 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Safety and Tolerability of Adjunctive Brivaracetam in Pediatric Patients < 16 Years with Epilepsy: An Open-Label Trial.

Liu Edwin E   Dilley Deanne D   McDonough Belinda B   Stockis Armel A   Daniels Tony T  

Paediatric drugs 20190801 4

<h4>Objective</h4>This trial evaluated the short-term safety and tolerability, steady-state pharmacokinetics, and preliminary efficacy of brivaracetam oral solution in children aged 1 month to < 16 years with epilepsy.<h4>Methods</h4>This was a phase IIa, open-label, single-arm, fixed three-step dose escalation trial of 3-weeks duration (N01263; NCT00422422). Patients were taking one to three concomitant antiepileptic drugs. Brivaracetam oral solution dosage, in two divided daily doses, was incr  ...[more]

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