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New drug shows promise for stopping deadly seizures

NCT ID NCT02052739

Disease control Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 tested a drug called SAGE-547 in 25 people with super-refractory status epilepticus, a condition where seizures continue despite standard treatments. The goal was to see if the drug is safe and tolerable. Participants received the drug by IV infusion, and researchers monitored for side effects and changes in health. The study is completed, but results are not yet widely available.

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 (a drug given by IV infusion)
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 drugs.
What could go wrong
This was a small, early-phase study (Phase 1/2) with only 25 participants, focused mainly on safety. It may not show clear benefit, and the drug could have side effects. More research is needed.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

25 people

The number who actually took part.

Started

Mar 2014

Finished

May 2015

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

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Participants 2 years of age and older. * Participants 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: * Participants with SRSE due to anoxic/hypoxic encephalopathy, children (participants aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder. * Participants with clinically significant electrocardiogram abnormalities. * Participants with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the participants 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. * Participants who are receiving a continuous IV AED (third-line agent) for seizure suppression or burst-suppression that would require greater than 24 hours to wean.

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Conditions

The condition(s) this trial relates to.

Status Epilepticus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Super-refractory status epilepticus

Contacts and locations

Locations

  • Sage Investigational Site

    Birmingham, Alabama, 35294, United States

  • Sage Investigational Site

    Sarasota, Florida, 34239, United States

  • Sage Investigational Site

    Chicago, Illinois, 60611, United States

  • Sage Investigational Site

    Wichita, Kansas, 67214, United States

  • Sage Investigational Site

    New Orleans, Louisiana, 70121, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02114, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02115, United States

  • Sage Investigational Site

    Ann Arbor, Michigan, 48109, United States

  • Sage Investigational Site

    Detroit, Michigan, 48322, United States

  • Sage Investigational Site

    New York, New York, 10032, United States

  • Sage Investigational Site

    Rochester, New York, 14642, United States

  • Sage Investigational Site

    Durham, North Carolina, 27710, United States

  • Sage Investigational Site

    Winston-Salem, North Carolina, 27157, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Sage Investigational Site

    Nashville, Tennessee, 37232, United States

  • Sage Investigational Site

    Dallas, Texas, 75251, United States

  • Sage Investigational Site

    Temple, Texas, 76504, United States

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Other studies related to the condition(s) this trial covers.