Trial · NCT02052739
Outcomes61
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 61
Download this page as JSON| 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 |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Aspartate 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. | IU/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Bicarbonate 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. | millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Bilirubin 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. | micromoles per liter (μmol/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen 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. | mmol/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Calcium 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. | mmol/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Chloride 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. | mmol/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase 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. | IU/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Creatinine 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. | μmol/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Glucose 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. | mmol/L | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameter: Lipase 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. | IU/L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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