CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A NEW DRUG (SAGE-547) INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

Phase 1

• Conditions: SUPER-REFRACTORY STATUS EPILEPTICUS (SRSE); MedDRA version: 19.0Level: PTClassification code 10041962Term: Status epilepticusSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-002142-31-AT
• Lead Sponsor: Sage Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-15
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Subjects 18 years of age and older.
2. Subjects who have:
• Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care, and;
• Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care, and;
• Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an EEG burst or seizure suppression pattern
Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1. Subjects who are pregnant.
2. Subjects with a known allergy to progesterone or allopregnanolone.
3. Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/malignant EEG features (Westhall, Rossetti et al. 2016);
4. Subjects who have any of the following:
-a GFR low enough to warrant dialysis but for whatever reason, dialysis that would adequately remove Captisol®is not planned s planned;
-severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
-fulminant hepatic failure;
-no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is less than 30 days;
5. Subjects who are being administered more than three third-line agents concomitantly or for whom the qualifying wean cannot be completed within 24 hours or who are being administered a third-line agent for indications such as raised intra-cranial pressure that would preclude weaning according to this protocol.
6. Subjects with a living will that does not allow heroic measure.
7. Subjects who have been exposed to an investigational medication or device within 30 days; the exception to this is that participation in the Established Status Epilepticus Treatment Trial or ESETT within 30 days of screening for the 547-SSE-301 trial is allowed.
8. Subjects who have been treated or randomized in this trial or any other trial employing SAGE-547 previously (i.e., subjects may not have received study drug/placebo and then re-enroll).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified