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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2017

At a glance

  • Drugs Brexanolone (Primary)
  • Indications Status epilepticus
  • Focus Expanded access; Registrational; Therapeutic Use
  • Acronyms Study 302
  • Sponsors Sage Therapeutics
  • Most Recent Events

    • 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.
    • 20 Apr 2015 The first patient has been enrolled, according to a SAGE Therapeutics media release; Study 302 will allow for the expedited treatment of patients who are located at hospitals that are not participating in the Phase 3 placebo-controlled clinical trial and who cannot be transferred to trial sites for medical or other reasons.
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