A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures.

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

03 Oct 2013 Based on data from this trial, Eisai received EC approval extending use of adjunctive Zonegran in the treatment of partial seizures (with or without secondary generalization) to include paediatric patients ≥6 years, according to a media release.
29 Jul 2013 The CHMP of the EMA has issued a positive opinion on on the license extension application for the use of zonisamide in paediatric patients, supported by data from this trial, according to an Eisai media release.
10 Jul 2013 Results of this pivotal paediatric trial were published in Epilepsia, according to an Eisai media release.

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