Trial · NCT02052739
Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
NCT02052739, Phase 1, Phase 2, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2022-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus. Trials, record NCT02052739. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052739
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus
- NCT number
- NCT02052739
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Super-refractory Status Epilepticus
- Interventions
- SAGE-547
- First posted
- 2014-02-03
- Last updated
- 2025-09-15
- Results first posted
- 2022-05-03
Source ClinicalTrials.gov
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 29 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs are defined as those that begin on or after initiation of the infusion of SAGE-547. |
| Primary | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | The National Institutes of Health Stroke Scale (NIH-SS) was used to examine the physical and neurological state of the participants. The NIH-SS is a 15-item assessment with measures of level of consciousness, visual gaze and vision loss, facial palsy, motor ability, ataxia, sensory ability, aphasia, dysarthria, and inattention. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment. |
| Primary | Change From Baseline in Vital Sign Parameter: Body Weight | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)), respiratory rate, temperature, oxygen saturation. CFB in body weight is reported in this outcome measure. |
| Primary | Change From Baseline in Vital Sign Parameter: Heart Rate | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended Follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in heart rate is reported in this outcome measure. |
| Primary | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72: 72 hour;73-96: 96 hour;97-120:120 hour;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8,15,22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in SBP and DBP is reported in this outcome measure. |
| Primary | Change From Baseline in Vital Sign Parameter: Respiratory Rate | Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in respiratory rate is reported in this outcome measure. |
| Primary | Change From Baseline in Vital Sign Parameter: Body Temperature | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in body temperature is reported in this outcome measure. |
| Primary | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. CFB in oxygen saturation is reported in this outcome measure. |
| Primary | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in alanine aminotransferase levels is reported in this outcome measure. |
| Primary | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in albumin levels is reported in this outcome measure. |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 registered outcomesOutcomes61
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Vital Sign Parameter: Body Weight | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | kilograms (kg) | MEAN |
| PRIMARY | Change From Baseline in Vital Sign Parameter: Heart Rate | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended Follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | beats per minute (beats/min) | MEAN |
| PRIMARY | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72: 72 hour;73-96: 96 hour;97-120:120 hour;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8,15,22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Vital Sign Parameter: Respiratory Rate | Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | breaths per min (breaths/min) | MEAN |
| PRIMARY | Change From Baseline in Vital Sign Parameter: Body Temperature | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | degrees Fahrenheit (F) | MEAN |
| PRIMARY | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | international units per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point. | grams per liter (g/L) | MEAN |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 outcomesResults by group1,329
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | SAGE-547 Standard Dose | 17 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | SAGE-547 High Dose | 6 | Participants | ||
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 Standard Dose | Baseline | 34.2 | Standard Deviation 4.69 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 High Dose | Baseline | 33.0 | Standard Deviation 4.86 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 Standard Dose | CFB at Infusion: 0-24 hours | 0.7 | Standard Deviation 2.30 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 High Dose | CFB at Infusion: 0-24 hours | 0.3 | Standard Deviation 1.51 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 Standard Dose | CFB at Infusion: 25-48 hours | 0.8 | Standard Deviation 3.47 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 High Dose | CFB at Infusion: 25-48 hours | -1.5 | Standard Deviation 6.19 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 Standard Dose | CFB at Infusion: 49-72 hours | -2.2 | Standard Deviation 6.70 | score on a scale |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | SAGE-547 High Dose | CFB at Infusion: 49-72 hours | -2.3 | Standard Deviation 4.63 | score on a scale |
1 to 10 of 1,329Source ClinicalTrials.gov
See all 1,329 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SAGE-547 Standard Dose | 19 | |
| Overall Study | STARTED | SAGE-547 High Dose | 6 | |
| Overall Study | COMPLETED | SAGE-547 Standard Dose | 14 | |
| Overall Study | COMPLETED | SAGE-547 High Dose | 5 | |
| Overall Study | NOT COMPLETED | SAGE-547 Standard Dose | 5 | |
| Overall Study | NOT COMPLETED | SAGE-547 High Dose | 1 |
Source ClinicalTrials.gov
Adverse events290
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 | Urinary tract infection | Infections and infestations | SAGE-547 Standard Dose | 1 | 19 | |
| other | Urinary tract infection | Infections and infestations | SAGE-547 High Dose | 2 | 6 | |
| other | Fungal skin infection | Infections and infestations | SAGE-547 Standard Dose | 1 | 19 | |
| other | Fungal skin infection | Infections and infestations | SAGE-547 High Dose | 1 | 6 | |
| other | Oral candidiasis | Infections and infestations | SAGE-547 Standard Dose | 1 | 19 | |
| other | Oral candidiasis | Infections and infestations | SAGE-547 High Dose | 1 | 6 | |
| other | Pneumonia | Infections and infestations | SAGE-547 Standard Dose | 1 | 19 | |
| other | Pneumonia | Infections and infestations | SAGE-547 High Dose | 1 | 6 | |
| other | Septic shock | Infections and infestations | SAGE-547 Standard Dose | 1 | 19 | |
| other | Septic shock | Infections and infestations | SAGE-547 High Dose | 1 | 6 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SAGE-547 Standard Dose | 5 | 19 |
| Total, all-cause mortality | SAGE-547 High Dose | 1 | 6 |
| Total, other adverse events | SAGE-547 Standard Dose | 15 | 19 |
| Total, other adverse events | SAGE-547 High Dose | 6 | 6 |
| Total, serious adverse events | SAGE-547 Standard Dose | 14 | 19 |
| Total, serious adverse events | SAGE-547 High Dose | 2 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28779545 | BACKGROUND |
Source PubMed
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants With Prior Anti-epileptic Drugs (AEDs) and Pressors Usage | Trial comparisons |
| SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants With Relapse - Re-Initiation of Third-Line Agent | Trial comparisons |
| SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants Who Survived | Trial comparisons |
| SAGE-547 Standard Dose vs SAGE-547 High Dose: deaths from any cause | Trial comparisons |
| SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants With Treatment Response (Treatment Responders) | Trial comparisons |
| SAGE-547 Standard Dose vs SAGE-547 High Dose: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| SAGE-547 Standard Dose vs SAGE-547 High Dose: 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/NCT02052739
GET https://conductscience.org/api/trials/v1/NCT02052739/registered?page=2