Trial · NCT02477618
A Study With SAGE-547 for Super-Refractory Status Epilepticus
NCT02477618, Phase 3, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2019-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study With SAGE-547 for Super-Refractory Status Epilepticus. Trials, record NCT02477618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02477618
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study With SAGE-547 for Super-Refractory Status Epilepticus
- NCT number
- NCT02477618
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 132 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Super-Refractory Status Epilepticus
- Interventions
- SAGE-547, Placebo
- First posted
- 2015-06-23
- Last updated
- 2025-10-14
- Results first posted
- 2019-05-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | Up to 21 days | 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. |
| Secondary | Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion | Day 6 | 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. |
| Secondary | Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | Up to 21 days | 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. |
| Secondary | Change in Clinical Global Impression Scale (CGI) | Up to 21 days | 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. |
| Secondary | Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12 | Up to 21 days | Here, study visits followed by "R" indicate the Open-label Treatment Period. |
| Secondary | Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12 | Up to 21 days | Here, study visits followed by "R" indicate the Open-label Treatment Period. |
| Secondary | Number of Separate Episodes of Status Epilepticus Up to Visit 12 | Up to 21 days | Here, study visits followed by "R" indicate the Open-label Treatment Period. |
| Secondary | Number of Participants With a New Diagnosis of Epilepsy After Visit 11 | Up to 21 days | Here, study visits followed by "R" indicate the Open-label Treatment Period. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 7 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, overall number of participants analyzed (N) indicates participants analyzed for this outcome measure. | days | MEDIAN |
| SECONDARY | Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion | Day 6 | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, overall number of participants analyzed (N) indicates participants analyzed for this outcome measure. | days | MEDIAN |
| SECONDARY | Change in Clinical Global Impression Scale (CGI) | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure. | units on scale | MEAN |
| SECONDARY | Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12 | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure. | days | MEAN |
| SECONDARY | Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12 | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure. | days | MEAN |
| SECONDARY | Number of Separate Episodes of Status Epilepticus Up to Visit 12 | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure. | episodes | MEAN |
| SECONDARY | Number of Participants With a New Diagnosis of Epilepsy After Visit 11 | Up to 21 days | The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Placebo | 28 | Participants | ||
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 | SAGE-547 | 29 | Participants | ||
| Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | Placebo | 13.500 | Full Range 0.06 to 18.00 | days | |
| Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | SAGE-547 | 14.000 | Full Range 0.18 to 16.00 | days | |
| Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion | Placebo | 45 | Participants | ||
| Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion | SAGE-547 | 38 | Participants | ||
| Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | Placebo | 7.000 | Full Range 0.00 to 20.00 | days | |
| Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression | SAGE-547 | 15.000 | Full Range 0.00 to 19.00 | days | |
| Change in Clinical Global Impression Scale (CGI) | Placebo | Baseline | 6.0 | Standard Deviation 0.89 | units on scale |
| Change in Clinical Global Impression Scale (CGI) | SAGE-547 | Baseline | 5.9 | Standard Deviation 1.31 | units on scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 65 | |
| Overall Study | STARTED | SAGE-547 | 67 | |
| Overall Study | Intent-to-Treat Analysis Set | Placebo | 66 | |
| Overall Study | Intent-to-Treat Analysis Set | SAGE-547 | 66 | |
| Overall Study | COMPLETED | Placebo | 50 | |
| Overall Study | COMPLETED | SAGE-547 | 53 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | SAGE-547 | 14 |
Source ClinicalTrials.gov
Adverse events230
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 7 | 65 | |
| other | Anaemia | Blood and lymphatic system disorders | SAGE-547 | 12 | 67 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 3 | 65 | |
| other | Leukocytosis | Blood and lymphatic system disorders | SAGE-547 | 4 | 67 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 7 | 65 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | SAGE-547 | 3 | 67 | |
| other | Tachycardia | Cardiac disorders | Placebo | 4 | 65 | |
| other | Tachycardia | Cardiac disorders | SAGE-547 | 8 | 67 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 2 | 65 | |
| other | Atrial fibrillation | Cardiac disorders | SAGE-547 | 5 | 67 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 12 | 65 |
| Total, all-cause mortality | SAGE-547 | 17 | 67 |
| Total, other adverse events | Placebo | 58 | 65 |
| Total, other adverse events | SAGE-547 | 60 | 67 |
| Total, serious adverse events | Placebo | 22 | 65 |
| Total, serious adverse events | SAGE-547 | 27 | 67 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAGE-547 vs Placebo: Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion | Trial comparisons |
SAGE-547 vs Placebo: 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 | Trial comparisons |
| SAGE-547 vs Placebo: deaths from any cause | Trial comparisons |
| SAGE-547 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02477618
GET https://conductscience.org/api/trials/v1/NCT02477618/results?page=2