Super-Refractory Status EpilepticusNCT02433314
An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus
A study testing SAGE-547 in people with Super-Refractory Status Epilepticus, run by Supernus Pharmaceuticals, Inc..
Trial summary
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Super-Refractory Status Epilepticus
- What is being tested?
- SAGE-547
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;
- severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
- fulminant hepatic failure;
- 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
About this study
Official title: An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects
- Conditions
- Super-Refractory Status Epilepticus
- Being tested
- SAGE-547
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE-547Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Super-Refractory Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrikas Vaitkevicius, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433314
- Sponsor's protocol ID
- 547-SSE-302
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2015
- Last updated
- 15 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus
- ClinicalTrials.gov ID
- NCT02433314
- Acronym / sponsor ID
- 547-SSE-302
- Conditions
- Super-Refractory Status Epilepticus
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects
Study design
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects six (6) months of age and older
- Subjects who have:
Key exclusion criteria (8 listed)
- 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:
- Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGE-547 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Related InfoLink provided by the sponsor.
Related trials for Super-Refractory Status Epilepticus
Not yet recruitingObservational study
Predictors of Outcomes of Convulsive Status Epilepticus
Status Epilepticus, Convulsive Status Epilepticus
Recruiting
KD Treatment for Super-refractory Status Epilepticus
Super-refractory Status Epilepticus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrikas Vaitkevicius, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing SAGE-547 in people with Super-Refractory Status Epilepticus, run by Supernus Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.