Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in subjects in super-refractory status epilepticus (SRSE).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone

Criteria

Inclusion Criteria:

• Subjects 2 years of age and older.

• Subjects with an EEG-confirmed SRSE diagnosis under concomitant therapy with a continuous IV AED (third-line agent) for ≥ 24 hours. For this study, SRSE is defined by the following criteria and in accordance with those used at major epilepsy treatment centers:

• Failure 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

• Failure 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

• Presence of one or more breakthrough seizures > 6 hours after initiation of the continuous IV AED/third-line agent (e.g., pentobarbital, midazolam, propofol)

Exclusion Criteria:

• Subjects with SRSE due to anoxic/hypoxic encephalopathy, children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder.

• Subjects with clinically significant electrocardiogram (ECG) abnormalities.

• Subjects with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the subject at increased risk such as dialysis or acute respiratory distress syndrome, severe cardiogenic or vasodilatory shock requiring 2 or more pressors, fulminant hepatic failure, etc.

• Subjects who are receiving a continuous IV AED (third-line agent) for seizure suppression or burst-suppression that will require greater than 24 hours to wean.