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New hope for deadly seizures: experimental drug SAGE-547 tested

NCT ID NCT02433314

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study offered SAGE-547, an experimental drug given as a continuous IV infusion, to people aged 6 months and older with super-refractory status epilepticus—a dangerous condition where seizures continue despite standard treatments. The goal was to see if the drug could help control these seizures. The study is no longer available for enrollment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAGE-547 injection
What this could lead to
If it works, this could provide a new treatment option for people with super-refractory status epilepticus, a life-threatening seizure condition that doesn't respond to standard medications.
What could go wrong
This is an expanded access program, not a controlled trial, so results are limited. The drug may not work for everyone, and side effects are possible. The study is no longer available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects six (6) months of age and older * 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 the institution's 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 AEDs), according to the institution's 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, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agents 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 at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an EEG burst or seizure suppression pattern. Exclusion Criteria: * Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features * Children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder * Subjects who have any of the following: 1. a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned; 2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use; 3. fulminant hepatic failure; 4. no reasonable expectation of recovery or life-expectancy of less than 30 days. * Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol

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As listed by the trial registrant

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