Trial Profile

An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 17 Nov 2017

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At a glance

10 Nov 2017 Status changed from recruiting to active, no longer recruiting.
23 Feb 2017 According to a SAGE Therapeutics media release, data from this and other trials in phase III development program will support Marketing Authorisation Application (MAA) for brexanolone to the European Medicine Agency.
20 Apr 2015 The results from this trial, along with results from SAGE's phase III placebo-controlled STATUS trial and other clinical data obtained from the SAGE-547 development program, are intended to form the basis of an NDA submission for SAGE-547, according to a SAGE Therapeutics media release.

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