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About the STATUS Trial

SAGE Therapeutics is currently sponsoring a clinical trial called the STATUS Trial to evaluate SAGE-547, an investigational medication for super-refractory status epilepticus (SRSE).

SAGE-547
Treatment as
Adjunctive
Therapy
Utilized in
Status Epilepticus

Trial Design

The STATUS Trial is 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 (SRSE).

About SAGE-547

SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors under investigation as an adjunctive agent in the treatment of SRSE. SAGE-547 was granted orphan drug and fast-track designations by the FDA to expedite clinical development and review for SRSE.

Trial Eligibility

Key Inclusion Criteria

Patients who present with status epilepticus and meet all of the following criteria:

Age:

  • 2 years of age or older (18 years or older in the following countries: Germany, Austria, Denmark, Sweden, United Kingdom, Spain and France)

First-line:

  • Failure to respond to at least one first-line agent, such as a benzodiazepine or other initial anti-epileptic drug (AED)

Second-line:

  • Failure to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam, or other continuous IV [cIV] AED)

Third-line: (one of the following)

  • No previous administration of a third-line agent, but patient is admitted to the ICU with the intent of administering at least one third-line agent for at least 24 hours
  • Previous failure of one or more wean attempts from third-line agent, and patient is now on cIV infusions of one or more third-line agents and is in an EEG burst suppression pattern
  • Previous failure of one or more wean attempts from third-line agents and patient is not in an EEG burst suppression pattern with or without a cIV infusion of at least one third-line agent

Key Exclusion Criteria

  1. SRSE due to anoxic/hypoxic encephalopathy
  2. Encephalopathy due to a rapidly progressing underlying neurological disorder in children under the age of 17
  3. A GFR low enough to warrant dialysis but continuous dialysis is not planned
  4. Fulminant hepatic failure
  5. Severe cardiogenic or vasodilatory shock not related to third-line agent use and requiring two or more pressors
  6. Administration of more than three third-line agents concomitantly
  7. Life expectancy less than 30 days
  8. Do not resuscitate (DNR) order or a living will that does not allow heroic measure

Identifying SRSE Patients for the STATUS Trial

Below outlines the treatment progression from when a patient first presents with status epilepticus until they become super-refractory.

Seizure begins.

After ~5 minutes

When a patient has a continuous seizure lasting more than 5 minutes, it is called status epilepticus. EMS administers first-line agents—benzodiazepines.

Treatment

First-line—Benzodiazepines

Location

At scene of seizure, en route to hospital

Condition

Status Epilepticus

After ~15 minutes

If the seizures are still not controlled by the time the patient reaches the emergency department, doctors begin second-line agents—cIV AEDs.

Treatment

Second-line—cIV (anti-epileptic drugs)

Location

Emergency Department

Condition

Status Epilepticus

After ~30 minutes

The patient is moved to the ICU if seizures continue and is given high-dose third-line agents (general anesthetics). These agents decrease brain activity for prolonged periods as measured by electroencephalogram called burst suppression.

Treatment

Third-line—general anesthetics for burst suppression

Location

ICU

Condition

Refractory Status Epilepticus

STATUS Trial Eligibility

Upon admission to the ICU, the patient may be eligible to receive SAGE-547 adjunctively with third-line agent(s).

Trial Candidate

  • ICU admission
  • Failed first- and second-line agents
  • Consent by legally authorized representative (LAR)

After ~24 hours

From this point forward, an attempt is made every 24-72 hours to wean the patient from third-line agents. If the patient fails to wean, the third-line agent is re-administered and the patient is randomly assigned to receive SAGE-547 or placebo (standard of care).

Treatment

Third-line + Adjunct SAGE-547

Location

ICU

Condition

Super-Refractory Status Epilepticus

Trial Candidate

  • Wean failure

If the patient fails to wean after receiving the assigned study medication, the patient is eligible for open-label retreatment with SAGE-547.

Please submit your other inquiries here.

Note: You must be a health care professional (HCP) to fill out this form. By clicking submit, you are confirming you are a health care professional. Please do not include any patient-identifying information.

Specify Your Inquiry (A selection is required.)

Please fill out this form if you have a potential patient for the Phase 3 SAGE-547 Treatment as Adjunctive Therapy Utilized in Status Epilepticus (STATUS) Trial.

Note: You must be a health care professional (HCP) to fill out this form. By clicking submit, you are confirming you are a health care professional. Please do not include any patient-identifying information.

Please fill out this form if you are interested becoming a site or investigator for the Phase 3 SAGE-547 Treatment as Adjunctive Therapy Utilized in Status Epilepticus (STATUS) Trial.

Note: You must be a health care professional (HCP) to fill out this form. By clicking submit, you are confirming you are a health care professional. Please do not include any patient-identifying information.

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