Super-Refractory Status EpilepticusPhase 3NCT02477618
A Study With SAGE-547 for Super-Refractory Status Epilepticus
A Phase 3 study testing SAGE-547 in people with Super-Refractory Status Epilepticus, run by Supernus Pharmaceuticals, Inc. at 171 sites in 16 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Super-Refractory Status Epilepticus
- What is being tested?
- SAGE-547
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 171 sitesin 16 countries
- Study dates
- Jun 2015to 11 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects two (2) years 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 anti-epileptic drug [AED] treatment), according to institution 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 AED), according to institution 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 agent 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 a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent 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 17 years) with an encephalopathy due to a rapidly progressing underlying neurological disorder
- Subjects who have any of the following:
- a glomerular filtration rate (GFR) low enough to warrant dialysis but for whatever reason, dialysis is not planned or non-continuous dialysis planned (that would not adequately remove Captisol®);
- 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 (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is 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
Trial locations and contacts
171 sites in 16 countries.
171 sites in 16 countries
United States100 sites
Sage Investigational Site
Akron, Ohio, 44308
Sage Investigational Site
Ann Arbor, Michigan, 48109
Sage Investigational Site
Atlanta, Georgia, 30303
Sage Investigational Site
Atlanta, Georgia, 30322
Sage Investigational Site
Atlanta, Georgia, 30342
Sage Investigational Site
Austin, Texas, 78723
Sage Investigational Site
Baltimore, Maryland, 21201
Sage Investigational Site
Baltimore, Maryland, 21215
Sage Investigational Site
Baton Rouge, Louisiana, 70808
Sage Investigational Site
Birmingham, Alabama, 35233
Sage Investigational Site
Boise, Idaho, 83706
Sage Investigational Site
Boston, Massachusetts, 02111
Sage Investigational Site
Boston, Massachusetts, 02114
Sage Investigational Site
Boston, Massachusetts, 02115
Sage Investigational Site
Boston, Massachusetts, 02118
Sage Investigational Site
Boston, Massachusetts, 02215
Sage Investigational Site
Buffalo, New York, 14203
Sage Investigational Site
Burlington, Vermont, 05401
Sage Investigational Site
Charleston, South Carolina, 29425
Sage Investigational Site
Chicago, Illinois, 60611
Sage Investigational Site
Chicago, Illinois, 60612
Sage Investigational Site
Cincinnati, Ohio, 45229
Sage Investigational Site
Cincinnati, Ohio, 45267
Sage Investigational Site
Cleveland, Ohio, 44195
Sage Investigational Site
Columbus, Ohio, 43210
Sage Investigational Site
Dallas, Texas, 75251
Sage Investigational Site
Detroit, Michigan, 48201
Sage Investigational Site
Detroit, Michigan, 48202
Sage Investigational Site
Durham, North Carolina, 27710
Sage Investigational Site
East Lansing, Michigan, 48824
Sage Investigational Site
Edison, New Jersey, 08818
Sage Investigational Site
Fresno, California, 93721
Sage Investigational Site
Gainesville, Florida, 32611
Sage Investigational Site
Grand Rapids, Michigan, 49503
Sage Investigational Site
Hershey, Pennsylvania, 17033
Sage Investigational Site
Honolulu, Hawaii, 96813
Sage Investigational Site
Honolulu, Hawaii, 96826
Sage Investigational Site
Huntington, West Virginia, 25705
Sage Investigational Site
Iowa City, Iowa, 52242
Sage Investigational Site
Jackson, Mississippi, 39216
Sage Investigational Site
Jacksonville, Florida, 32209
Sage Investigational Site
Kansas City, Missouri, 64108
Sage Investigational Site
Lexington, Kentucky, 40536
Sage Investigational Site
Little Rock, Arkansas, 27702
Sage Investigational Site
Loma Linda, California, 92354
Sage Investigational Site
Los Angeles, California, 90027
Sage Investigational Site
Louisville, Kentucky, 40202
Sage Investigational Site
Maywood, Illinois, 60153
Sage Investigational Site
Memphis, Tennessee, 38105
Sage Investigational Site
Miami, Florida, 33155
Sage Investigational Site
Minneapolis, Minnesota, 55414
Sage Investigational Site
Mobile, Alabama, 36667
Sage Investigational Site
Morgantown, West Virginia, 26506
Sage Investigational Site
Morristown, New Jersey, 08827
Sage Investigational Site
Nashville, Tennessee, 37232
Sage Investigational Site
New Brunswick, New Jersey, 08901
Sage Investigational Site
New Haven, Connecticut, 06510
Sage Investigational Site
New Orleans, Louisiana, 70115
Sage Investigational Site
New York, New York, 10016
Sage Investigational Site
New York, New York, 10029
Sage Investigational Site
New York, New York, 10032
Sage Investigational Site
Newton, Massachusetts, 02462
Sage Investigational Site
Orlando, Florida, 32803
Sage Investigational Site
Peoria, Illinois, 61637
Sage Investigational Site
Philadelphia, Pennsylvania, 19104
Sage Investigational Site
Philadelphia, Pennsylvania, 19107
Sage Investigational Site
Philadelphia, Pennsylvania, 19140
Sage Investigational Site
Philadelphia, Pennsylvania, 19141
Sage Investigational Site
Philadelphia, Pennsylvania, 19147
Sage Investigational Site
Phoenix, Arizona, 85006
Sage Investigational Site
Phoenix, Arizona, 85013
Sage Investigational Site
Pittsburgh, Pennsylvania, 15212
Sage Investigational Site
Port Jefferson, New York, 11777
Sage Investigational Site
Portland, Maine, 04102
Sage Investigational Site
Portland, Oregon, 97213
Sage Investigational Site
Portland, Oregon, 97225
Sage Investigational Site
Portland, Oregon, 97239
Sage Investigational Site
Rochester, Minnesota, 55905
Sage Investigational Site
Rochester, New York, 14642
Sage Investigational Site
Roseville, California, 95661
Sage Investigational Site
Royal Oak, Michigan, 48073
Sage Investigational Site
Sacramento, California, 95317
Sage Investigational Site
Salt Lake City, Utah, 84108
Sage Investigational Site
Salt Lake City, Utah, 84113
Sage investigational Site
San Antonio, Texas, 78229
Sage Investigational Site
Sarasota, Florida, 34239
Sage Investigational Site
Seattle, Washington, 98105
Sage Investigational Site
Springfield, Illinois, 62702
Sage Investigational Site
St Louis, Missouri, 63110
Sage Investigational Site
Summit, New Jersey, 07901
Sage Investigational Site
Syracuse, New York, 13210
Sage Investigational Site
Tampa, Florida, 33613
Sage Investigational Site
Toledo, Ohio, 43614
Sage Investigational Site
Urbana, Illinois, 61801
Sage Investigational Site
Washington D.C., District of Columbia, 20010
Sage Investigational Site
Wauwatosa, Wisconsin, 53226
Sage Investigational Site
Weston, Florida, 33331
Sage Investigational Site
Wichita, Kansas, 67214
Sage Investigational Site
Wilmington, Delaware, 19803
Sage Investigational Site
Winston-Salem, North Carolina, 27157
Italy13 sites
Sage Investigational Site
Bologna, 40139
Sage Investigational Site
Florence, 50139
Sage Investigational Site
Milan, 20132
Sage Investigational Site
Milan, 20132
Sage Investigational Site
Milan, 20133
Sage Investigational Site
Modena, 41100
Sage Investigational Site
Modena, 41126
Sage Investigational Site
Monza, 20900
Sage Investigational Site
Perugia, 06129
Sage Investigational Site
Reggio Calabria, 89124
Sage Investigational Site
Rome, 00165
Sage Investigational Site
Rome, 165
Sage Investigational Site
Verona, 37126
Canada9 sites
Sage Investigational Site
Hamilton, Ontario, L8L 2X2
Sage Investigational Site
Kingston, Ontario, K7L3C9
Sage Investigational Site
London, Ontario, N6A5A5
Sage Investigational Site
Montreal, Quebec, H1T 2M4
Sage Investigational Site
Montreal, Quebec, H2L 4M1
Sage Investigational Site
Montreal, Quebec, H3A 2B4
Sage Investigational Site
Montreal, Quebec, H3T 1C5
Sage Investigational Site
Montreal, Quebec, H3T1C5
Sage Investigational Site
Vancouver, British Columbia, V6H3V4
Spain8 sites
Sage Investigational Site
Badalona, 8916
Sage Investigational Site
Barakaldo, 48903
Sage Investigational Site
Barcelona, 08035
Sage Investigational Site
Barcelona, 08036
Sage Investigational Site
Córdoba, 14004
Sage Investigational Site
Granada, 18016
Sage Investigational Site
L'Hospitalet de Llobregat, 08907
Sage Investigational Site
Madrid, 28040
Israel7 sites
Sage Investigational Site
Ashkelon, 7830604
Sage Investigational Site
Holon, 58100
Sage Investigational Site
Holon
Sage Investigational Site
Jerusalem, 91120
Sage Investigational Site
Petah Tikva, 49100
Sage Investigational Site
Tel Litwinsky, 52621
Sage Investigational Site
Tzrifin, 70300
France6 sites
Sage Investigational Site
Bron, 69677
Sage Investigational Site
Dijon, 21079
Sage Investigational Site
Lille, 59037
Sage Investigational Site
Limoges, 87042
Sage Investigational Site
Lyon, 69677
Sage Investigational Site
Paris, 75851
United Kingdom5 sites
Sage Investigational Site
Manchester, M6 8HD
Sage Investigational Site
Norfolk, NR4 7UY
Sage Investigational Site
Norwich, NR4 7UY
Sage Investigational Site
Staffordshire, ST3 6QG
Sage Investigational Site
Stoke-on-Trent, ST4 6QG
Netherlands4 sites
Sage Investigational Site
Enschede, 7512KZ
Sage Investigational Site
Heerlen, 6419PC
Sage Investigational Site
Maastricht, 6202AZ
Sage Investigational Site
Nijmegen, 6525GA
Serbia4 sites
Sage Investigational Site
Belgrade, 11000
Sage Investigational Site
Belgrade, 11070
Sage Investigational Site
Niš, 18000
Sage Investigational Site
Novi Sad, 21000
Estonia3 sites
Sage Investigational Site
Tallinn, 10617
Sage Investigational Site
Tallinn, 13419
Sage Investigational Site
Tartu, 51014
Germany3 sites
Sage Investigational Site
Hamburg, 22337
Sage Investigational Site
Marburg, 35043
Sage Investigational Site
Osnabrück, 49076
Hungary3 sites
Sage Investigational Site
Balassagyarmat, 2660
Sage Investigational Site
Budapest, 01134
Sage Investigational Site
Budapest, 1134
Austria2 sites
Sage Investigational Site
Innsbruck, 6020
Sage Investigational Site
Salzburg, 5020
Finland2 sites
Sage Investigational Site
Helsinki, 00029
Sage Investigational Site
Kuopio, 70210
About this study
Official title: 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
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).
- Conditions
- Super-Refractory Status Epilepticus
- Being tested
- SAGE-547, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE-547Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SAGE-547 | Active comparator | Intravenous Receives: Drug: SAGE-547 |
| Placebo | Placebo comparator | Intravenous Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for >=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Measured: 7 days
Secondary outcomes (8)
Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for >=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
Measured: Up to 21 days
Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Measured: Day 6
Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.
Measured: Up to 21 days
Change in Clinical Global Impression Scale (CGI)
The CGI scale was used to integrate several sources of information into a single rating of a participant's condition. The CGI was rated on a 7-point scale, from a minimum of 0 to a maximum of 7, where 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline physically ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill participants. A negative change from baseline indicates improvement. A positive change from baseline indicates worsening. Here, study visits followed by "R" indicate the Open-label Treatment Period.
Measured: Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Measured: Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Measured: Up to 21 days
Number of Separate Episodes of Status Epilepticus Up to Visit 12
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Measured: Up to 21 days
Number of Participants With a New Diagnosis of Epilepsy After Visit 11
Here, study visits followed by "R" indicate the Open-label Treatment Period.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion18 Jul 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Rosenthal, MD, Principal investigator, Massachusetts General HospitalMark Wainwright, MD, PhD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477618
- Sponsor's protocol ID
- 547-SSE-301
- Status last verified
- Jan 2022
- First submitted
- 2 Jun 2015
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02477618
- Acronym / sponsor ID
- 547-SSE-301
- Conditions
- Super-Refractory Status Epilepticus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAGE-547 | Active comparator | Drug: SAGE-547Intravenous |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects two (2) years 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 17 years) with an encephalopathy due to a rapidly progressing underlying 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 | SAGE-547 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion
Time frame: 7 days
Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for >=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.
8 secondary outcomes
Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Time frame: Up to 21 days
Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion
Time frame: Day 6
Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression
Time frame: Up to 21 days
Change in Clinical Global Impression Scale (CGI)
Time frame: Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12
Time frame: Up to 21 days
Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12
Time frame: Up to 21 days
Number of Separate Episodes of Status Epilepticus Up to Visit 12
Time frame: Up to 21 days
Number of Participants With a New Diagnosis of Epilepsy After Visit 11
Time frame: Up to 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sage TherapeuticsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Related trials for Super-Refractory 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.
Eric Rosenthal, MD principal investigator
Massachusetts General Hospital
Mark Wainwright, MD, PhD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
171 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SAGE-547 in people with Super-Refractory Status Epilepticus, run by Supernus Pharmaceuticals, Inc. at 171 sites in 16 countries.
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: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 171 sites in United States, Italy, Canada, Spain, Israel and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion (time frame: 7 days). It is what the study was designed to measure, not a finding.
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 14 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.