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
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
- 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.