STATUS trial
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS
IRAS ID
204366
Contact name
Maxwell Damian
Contact email
Sponsor organisation
Sage Therapeutics
Eudract number
2015-002142-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117901, IND number
Duration of Study in the UK
0 years, 11 months, 2 days
Research summary
This is a Phase 3 randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 Injection administered as a continuous intravenous infusion to subjects in Super-Refractory
Status Epilepticus (SRSE). SRSE is a condition in which patients experience continuous seizures and have failed to respond to seizure medications. If a patient does not respond to seizure medications, they are admitted to the intensive care unit and given anesthetic medications to place them in a medically induced coma. If the patient cannot be withdrawn from anesthetic medications without seizures returning, they are said to be in SRSE.
Patients with SRSE aged 18 years and older will be randomized to SAGE-547 or placebo in a 1:1 ratio with 70 patients randomized to SAGE-547 and 70 subjects randomized to placebo. Regardless of whether the patient is assigned to the active (SAGE-547) treatment group or to the placebo group, during the 6 day infusion he/she will receive all other medications and treatments as the standard of medical care for his/her condition. If the patient continues to have continuous seizures during the 24 hours following the end of the initial randomized treatment period, the patient may be eligible to receive SAGE-547 during the retreatment period.
The study will be conducted in intensive care units of several hospital and patient participation in the study could last up to 35 days. Participants will receive all standard medical tests and procedures to treat their SRSE including laboratory tests, vital sign measurements, EEG, and ECG. Participants will also be asked to consent to additional blood samples to measure levels of SAGE-547, a pregnancy test for females who are able to have children, and a sample for genetics research.REC name
London - South East Research Ethics Committee
REC reference
16/LO/1215
Date of REC Opinion
27 Jul 2016
REC opinion
Favourable Opinion