Explore a clinical trial for SRSE


If your loved one’s seizures won’t stop, he or she may develop Super-Refractory Status Epilepticus (SRSE). Learn more about the severity and management of SRSE.
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The STATUS Trial

The STATUS Trial is an evaluation of the safety and effectiveness of an investigational drug in patients with continuous seizures (seizures that have little or no break between them).

Your friend, family member or loved one may be eligible to participate in the STATUS Trial if he/she:

  • Has failed to respond to seizure medications, and
  • Has been admitted to the intensive care unit (ICU), and
  • Cannot be withdrawn from the anesthetic medications keeping him/her in a medically induced coma.

The goal of SRSE treatment is to stop continuous seizures as soon as possible. There are no FDA-approved medications for SRSE.

When considering a clinical trial, it is important to understand that there are potential risks involved. The study doctor will be able to discuss these risks with you.

What is SRSE?

Super-refractory status epilepticus is a medical emergency in which patients experience continuous seizures (seizures that have little or no break between them) that do not stop even after standard treatment attempts in the ICU have not been effective in controlling the ongoing seizure.

Patients whose seizures continue despite the anti-seizure medication have refractory status epilepticus (RSE) and must be admitted to the Intensive Care Unit (ICU) or neurocritial care unit (NCCU) to be placed in a medically induced coma using anesthesia. The treatment team approach is to continue to try to turn off the anesthesia to see whether the status epilepticus returns. If it does, patients are placed back on anesthesia into a medically induced coma with the same or different medications.

It is important to know that treating SRSE can be challenging and the process may vary from several hours to days, weeks or even months.

What causes SRSE?

SRSE can occur due to a variety of different factors. However, the most common causes include:

  • Brain injury, including:
    • Bleeds
    • Tumors
    • Infections
    • Trauma
  • Poor compliance with anti-seizure medications
  • Epilepsy syndromes
  • Fever (children)
  • Autoimmune conditions

What is a Seizure?

A seizure is a sudden surge of electrical activity in the brain like an electrical storm. Symptoms of seizures may be different each time and in each person, and most seizures do not last longer than two minutes.

Symptoms of SRSE may sometimes be related to common forms of epilepsy—a neurological condition defined by a person having at least two seizures not caused by a medical condition—but a patient does not have to have epilepsy to experience SRSE.

The Patient Journey

The below graphic shows the progression from the time a patient first experiences a seizure through multiple lines of therapy to SRSE.

~0 - 5 min
Seizures Start

 

  • Anti-seizure medications
~5 - 30 min
Status Epilepticus (SE)

ER

  • Seizure continues
  • Anti-seizure medications
  • Continue to treat underlying condition
Patient should be monitored as he/she may develop into an SRSE patient.
~30 min - 24 hours
Refractory Status Epilepticus (RSE)

ICU

  • Seizure continues
  • Anesthetic medications
  • Medically induced coma
  • Continue to treat underlying condition
~24 hrs+
Super-Refractory Status Epilepticus (SRSE)

ICU

  • Anesthetic medications
  • Failure to wake from medically induced coma without continued seizures
  • Continue to optimize treatment approach

Get More Information

If your friend, family or loved one is in SRSE, you can be their advocate.

DOWNLOAD SRSE BROCHURE

The SRSE Brochure provides information about super-refractory status epilepticus (SRSE) and may help you understand what to expect when your loved one is in the hospital with continuous seizures.

DOWNLOAD TRIAL INFO

The STATUS Trial Information Sheet offers information about the STATUS Trial. Share this information with your doctor to see whether or not the STATUS Trial may be an option.

DOWNLOAD FOR YOUR PHYSICIAN

The For Your Physician form is an informational tool designed for you to share with your physician. Bring this to your doctor to help discuss STATUS Trial eligibility.

Frequently Asked Questions (FAQs)

FAQs: The STATUS Trial

  • What is the purpose of the STATUS Trial?
    The purpose of the STATUS Trial is to find out if an investigational drug/medicine (SAGE-547), also known as a study drug, is effective in stopping continuous seizures that have failed to respond to standard treatments, including anesthesia (which is a condition called super-refractory status epilepticus [SRSE]), and if it is safe to use in patients in SRSE in addition to their ongoing treatment.
  • What is SAGE-547?
    SAGE-547 Injection (SAGE-547) is an investigational drug being studied in patients with continuous seizures (seizures that have little or no break between them) that do not respond to standard treatments, including anesthesia (a condition called SRSE).
  • How long is the STATUS Trial?
    The patient’s participation in this study could last up to 35 days and could potentially include 20 assessment time points based on the required treatment. Most of these assessments are done during the course of the patient’s ongoing treatment.
  • What is a placebo, and could my loved one receive one in the STATUS Trial?
    Regardless if the patient is assigned to the study treatment group or to the placebo group he/she will receive all other medications and treatments as per a standard of medical care and as deemed most appropriate by the doctor for his/her condition.

    Placebos are inactive substances made to look like the study drug used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment alone.

    In this study, the patient will be randomly assigned the chance (like a flip of a coin) to receive either SAGE-547 (study substance) or placebo (inactive substance) during the initial study treatment period. The random assignment means that the subject will have 50% chance (1 in 2) of receiving SAGE-547 and 50% (1 in 2) of receiving placebo. This is a double-blind study, which means neither you, the patient, nor the study doctor will know to which of these groups the patient is assigned.
  • Who is sponsoring the STATUS Trial?
    Sage Therapeutics is sponsoring the STATUS Trial.
  • Will I have to pay for anything if I choose to participate in the STATUS Trial?
    All study procedures not related to the patient’s regular medical care, including laboratory tests, physical examinations, and study medication will be provided free of charge. However, the cost of certain laboratory tests and/or certain medical procedures that are performed as part of the patient’s regular medical care will be billed to his/her health insurance. If the patient’s insurance doesn’t pay or if the patient does not have health insurance, he/she may be billed for those charges.
  • What if the patient does not respond to treatment?
    If the patient’s medication(s) to stop their continuous seizures, which make him/her unconscious, are unable to be stopped during the initial study treatment course or need to be restarted within 24 hours of the conclusion of the initial study treatment course, the patient may be able to receive a re-treatment with the study drug. The retreatment is open-label, which means you and the study doctor will know the patient is receiving the study drug SAGE-547.

FAQs: General

  • What is a clinical trial?
    A clinical trial evaluates the safety and effectiveness of an investigational drug. A clinical trial can provide information on whether the investigational drug is better than, as good as, or no better than the standard treatment or placebo. Qualified doctors, nurses and other medical professionals conduct the trial.

    It is only through the completion of clinical research studies that the investigational drug can be evaluated, and if proven safe and effective, the drug is approved for use in the condition that was studied. Clinical trials are performed according to government regulations that help protect the safety and rights of the participants.
  • What is an investigational drug?
    An investigational drug is a study medication that is not approved for use or prescription by doctors for the condition being studied. Investigational drugs are tested during clinical trials to see if they are safe and effective for a specific medical condition and/or group of people.
  • Is participation in a clinical trial voluntary?
    Participation in any clinical trial is completely voluntary. If you decide to participate in a clinical trial, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.
  • What are the risks of participating in a clinical trial?
    Your friend, family or loved one could experience side effects associated with the investigational drug. There are also risks associated with some of the study procedures. The symptoms may not improve or may get worse during the trial. The doctor or trial staff will discuss all of the possible risks and potential benefits in detail with you.
  • What is informed consent?

    Informed consent is the process of learning the key facts about a clinical trial before you decide to participate. It is also a continuing process throughout the study to provide information to participants. To help you decide whether or not to participate, the doctors and nurses involved in the clinical trial will explain the details of the study. The study team will then provide you with an informed consent form to read. The document includes details about the study, such as its purpose, duration and required procedures. Risks and potential benefits are also explained in the informed consent form. After you have received and read the information about the clinical research study, you will then decide whether or not to sign the document. No study-related procedures can take place before you have signed the informed consent form. The informed consent form is not a contract, and you may withdraw from the clinical trial at any time.
  • Is my loved one’s personal information kept private?
    The information you provide will not be shared with anyone who is not directly associated with this trial without your permission (except as required by law) or as set forth in the informed consent.
  • Why is my loved one in SRSE if they don’t have epilepsy?
    Symptoms of SRSE may sometimes be related to common forms of epilepsy—a neurological condition defined by a person having at least two seizures not caused by a medical condition. Most epileptic seizures stop on their own or after seizure medications are administered. However, when a seizure is continuous and lasts for a prolonged duration, even after standard treatment attempts in the ICU have not been effective in controlling the ongoing seizure, the patient may have super-refractory status epilepticus (SRSE). A patient does not have to have epilepsy in order to experience SRSE.