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Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb.
Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 (Double-blind): SAGE 547, Then Placebo | Experimental | Participants received a 12-hour intravenous (IV) infusion of SAGE 547, at ascending doses of 29, 58, and 86 micrograms per kilogram of body weight per hour (μg/kg/h), 4 hours each, on Day 1 of Stage 1 [Treatment Period 1 (TP 1)]. After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE-547 matching-placebo, on Day 10 of Stage 1 [Treatment Period 2 (TP 2)]. |
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| Stage 1 (Double-blind): Placebo, Then SAGE-547 | Experimental | Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1). After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2). |
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| Stage 2 (Open Label): SAGE-547 | Experimental | Participants who completed Stage 1 were invited to receive a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-547 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition. | Stage 1: Up to 30 days after last infusion (up to Day 40) |
| Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition. | Stage 2: Up to 30 days after last infusion (up to Day 31) |
| Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present [from 1 (minor physical damage) to 5 (death), with 5 being most severe]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Change From Baseline in Accelerometer Total Score Response | Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing-beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Lasser, MD, MBA | Sage Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Study Site | Bingham Farms | Michigan | United States | |||
| Sage Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Aaron Ellenbogen, Shane Raines, Stephen Kanes. Exploratory trial results for SAGE-547 in essential tremor. Presented at AAN, April 19, 2016 P4.297. MRC-ZUL-00141_Exploratory Trial Results for SAGE-547 in Essential Tremor. |
| Label | URL |
|---|---|
| Sage Therapeutics | View source |
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Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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This study consisted of two stages, Stages 1 and 2. Stage 1 had two periods with treatment on Days 1 and 10 and a 7-day follow-up period. Participants were followed for serious adverse events (SAEs) up to 30 days after the last dose. Stage 2 follows Stage 1, with treatment on Day 1 and a 7-day follow-up period thereafter.
Participants were enrolled at 2 investigative sites in the United States from 23 September 2014 to 14 August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 (Double-blind): SAGE 547, Then Placebo | Participants received a 12-hour intravenous (IV) infusion of SAGE 547, at ascending doses of 29, 58, and 86 micrograms per kilogram of body weight per hour (μg/kg/h), 4 hours each, on Day 1 of Stage 1 [Treatment Period 1 (TP 1)]. After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE-547 matching-placebo, on Day 10 of Stage 1 [Treatment Period 2 (TP 2)]. |
| FG001 | Stage 1 (Double-blind): Placebo, Then SAGE-547 | Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1). After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2). |
| FG002 | Stage 2 (Open Label): SAGE-547 | Participants who completed Stage 1 were invited to receive a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1: Treatment Period 1 |
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| Washout |
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| Stage 1: Treatment Period 2 |
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| Stage 2 |
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Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 (Double-blind): SAGE-547 and Placebo | Participants who received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1), received a 12-hour IV infusion of SAGE-547 matched-placebo, on Day 10 of Stage 1 (TP 2), after a washout period of approximately 7 days. Participants who received a 12-hour IV infusion of SAGE-547 matched-placebo on Day 1 of Stage 1 (TP 1), received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2), after a washout period of approximately 7 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Number | percentage of participants | Stage 1: Up to 30 days after last infusion (up to Day 40) |
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Stage 1: Up to 30 days after last infusion (up to Day 40); Stage 2: Up to 30 days after last infusion (up to Day 31)
Safety population for Stage 1 included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. The safety population for Stage 2 included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1: SAGE-547 | Participants received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Sage Therapeutics | (617) 299-8380 | info@sagerx.com |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000625635 | brexanolone |
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| Placebo | Drug |
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| Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2) |
| Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present [from 1 (minor physical damage) to 5 (death), with 5 being most severe]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. | Stage 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion |
| Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alanine aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alanine aminotransferase levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in aspartate aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for aspartate aminotransferase levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in gamma glutamyl transferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for gamma glutamyl transferase levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in sodium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for sodium levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in potassium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for potassium levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in calcium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for calcium levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in chloride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for chloride levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bicarbonate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bicarbonate levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in protein levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for protein levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in glucose levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for glucose levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in lactate dehydrogenase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for lactate dehydrogenase levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in cholesterol levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for cholesterol levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in triglyceride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for triglyceride levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in albumin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for albumin levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bilirubin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bilirubin levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in blood urea nitrogen levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for blood urea nitrogen levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alkaline phosphatase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alkaline phosphatase levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine kinase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine kinase levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in phosphate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for phosphate levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in urate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for urate levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hemoglobin levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hematocrit levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hematocrit levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in platelet levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Platelet Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for platelet levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocyte levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in neutrophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for neutrophil levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in basophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Basophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for basophil levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in eosinophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for eosinophil levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in monocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for monocyte levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in lymphocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for lymphocyte levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in leukocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for leukocyte levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocytes mean corpuscular volume levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in mean cell hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
| Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for mean cell hemoglobin levels are reported in this outcome measure. | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
| Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion |
| Stage 2: Change From Baseline in ECG Parameter - QT Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
| Stage 1: Change From Baseline in ECG Parameter - PR Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion |
| Stage 2: Change From Baseline in ECG Parameter - PR Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
| Stage 1: Change From Baseline in ECG Parameter - QRS Duration | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
| Stage 2: Change From Baseline in ECG Parameter - QRS Duration | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
| Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
| Stage 2: Change From Baseline in ECG Parameter - QTcB Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
| Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
| Stage 2: Change From Baseline in ECG Parameter - QTcF Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
| Stage 1: Change From Baseline in ECG Parameter - Heart Rate | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
| Stage 2: Change From Baseline in ECG Parameter - Heart Rate | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
| Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Accelerometer Total Score Response | Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage. | Stage 2 Day 1: Baseline and 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours |
| Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor [right], forward outstretched postural tremor [left], lateral wing-beating postural tremor [right], lateral wing-beating postural tremor [left], kinetic tremor [right], kinetic tremor [left], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the pre-infusion value in each period/stage. | Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor [right], forward outstretched postural tremor [left], lateral wing-beating postural tremor [right], lateral wing-beating postural tremor [left], kinetic tremor [right], kinetic tremor [left], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. | Stage 2 Day 1: Baseline and at 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours |
| Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness. | Stage 1 Day 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion |
| Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness. | Stage 2 Day 1: Baseline and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours |
| Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
| Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
| Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
| Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
| Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
| Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | Day 1: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
| Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
| Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
| Stage 1: Clearance (CL) of SAGE-547 | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
| Stage 2: Clearance (CL) of SAGE-547 | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
| Stage 1: Terminal Half-Life (t½) of SAGE-547 | Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium. | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
| Stage 2: Terminal Half-Life (t½) of SAGE-547 | Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium. | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
| Raleigh |
| North Carolina |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG000 |
| Stage 1: SAGE-547 |
Participants received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2). |
| OG001 | Stage 1: Placebo | Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2). |
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| Primary | Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Number | percentage of participants | Stage 2: Up to 30 days after last infusion (up to Day 31) |
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| Primary | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present [from 1 (minor physical damage) to 5 (death), with 5 being most severe]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Number | percentage of participants | Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2) |
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| Primary | Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present [from 1 (minor physical damage) to 5 (death), with 5 being most severe]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Number | percentage of participants | Stage 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion |
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| Primary | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mmHg | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mmHg | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mmHg | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | bpm | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1 . | Posted | Mean | Standard Deviation | mmHg | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mmHg | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mmHg | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mmHg | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | bpm | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | bpm | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | degree Celsius | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | degree Celsius | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | breaths per minute (breaths/min) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | breaths/min | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alanine aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | units per liter (u/L) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alanine aminotransferase levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | u/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in aspartate aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | u/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for aspartate aminotransferase levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | u/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in gamma glutamyl transferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 Stage 1. | Posted | Mean | Standard Deviation | u/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for gamma glutamyl transferase levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | u/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in sodium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for sodium levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mmol/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in potassium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mmol/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for potassium levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mmol/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in calcium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for calcium levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in chloride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mmol/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for chloride levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mmol/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bicarbonate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mmol/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bicarbonate levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mmol/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in protein levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for protein levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | g/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in glucose levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for glucose levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in lactate dehydrogenase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | u/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for lactate dehydrogenase levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | u/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in cholesterol levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for cholesterol levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in triglyceride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for triglyceride levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in albumin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | g/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for albumin levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | g/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bilirubin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bilirubin levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in blood urea nitrogen levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for blood urea nitrogen levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alkaline phosphatase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | u/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alkaline phosphatase levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | u/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine kinase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | u/L | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine kinase levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | u/L | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in phosphate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for phosphate levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in urate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for urate levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | mg/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | g/dL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hemoglobin levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | g/dL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hematocrit levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | percentage of cells | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hematocrit levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | percentage of cells | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in platelet levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | 10^3 cells per microliter(10^3 cells/μL) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Platelet Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for platelet levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | 10^6 cells per microliter(10^6 cells/μL) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocyte levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | 10^6 cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in neutrophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for neutrophil levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in basophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | cells per microliter (cells/μL) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Basophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for basophil levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in eosinophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | cells/μL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for eosinophil levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in monocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | cells/μL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for monocyte levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in lymphocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | cells/μL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for lymphocyte levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in leukocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for leukocyte levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | femtoliter (fL) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocytes mean corpuscular volume levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | fL | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in mean cell hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | picograms (pg) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion |
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| Primary | Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for mean cell hemoglobin levels are reported in this outcome measure. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | pg | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up |
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| Primary | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Median | Full Range | milliseconds (msec) | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion |
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| Primary | Stage 2: Change From Baseline in ECG Parameter - QT Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Median | Full Range | msec | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in ECG Parameter - PR Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Median | Full Range | msec | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion |
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| Primary | Stage 2: Change From Baseline in ECG Parameter - PR Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Median | Full Range | msec | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Median | Full Range | msec | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
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| Primary | Stage 2: Change From Baseline in ECG Parameter - QRS Duration | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Median | Full Range | msec | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Median | Full Range | msec | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
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| Primary | Stage 2: Change From Baseline in ECG Parameter - QTcB Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Median | Full Range | msec | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Median | Full Range | msec | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
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| Primary | Stage 2: Change From Baseline in ECG Parameter - QTcF Interval | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Median | Full Range | msec | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
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| Primary | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | Posted | Mean | Standard Deviation | bpm | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion |
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| Primary | Stage 2: Change From Baseline in ECG Parameter - Heart Rate | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | bpm | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion |
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| Secondary | Stage 1: Change From Baseline in Accelerometer Total Score Response | Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing-beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage. | Efficacy population was defined as all participants in the safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2 of Stage 1. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | score on a scale | Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion |
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| Secondary | Stage 2: Change From Baseline in Accelerometer Total Score Response | Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage. | Efficacy population was participants from safety population, who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | score on a scale | Stage 2 Day 1: Baseline and 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours |
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| Secondary | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor [right], forward outstretched postural tremor [left], lateral wing-beating postural tremor [right], lateral wing-beating postural tremor [left], kinetic tremor [right], kinetic tremor [left], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the pre-infusion value in each period/stage. | Efficacy population was defined as all participants in the safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2 of Stage 1. | Posted | Mean | Standard Deviation | score on a scale | Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion |
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| Secondary | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor [right], forward outstretched postural tremor [left], lateral wing-beating postural tremor [right], lateral wing-beating postural tremor [left], kinetic tremor [right], kinetic tremor [left], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. | Efficacy population was participants from safety population, who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | score on a scale | Stage 2 Day 1: Baseline and at 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours |
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| Secondary | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness. | Efficacy population was defined as all participants in the safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Stage 1 Day 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion |
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| Secondary | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness. | Efficacy population was participants from safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | Posted | Mean | Standard Deviation | score on a scale | Stage 2 Day 1: Baseline and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours |
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| Secondary | Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Pharmacokinetic (PK) population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
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| Secondary | Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | ng/mL | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
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| Secondary | Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Median | Full Range | hours | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
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| Secondary | Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2. | Posted | Median | Full Range | hours | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
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| Secondary | Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Mean | Standard Deviation | nanograms*hours per milliliter (ng*h/mL) | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
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| Secondary | Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | ng*h/mL | Day 1: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
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| Secondary | Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Mean | Standard Deviation | ng*h/mL | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
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| Secondary | Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | ng*h/mL | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
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| Secondary | Stage 1: Clearance (CL) of SAGE-547 | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. | PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Mean | Standard Deviation | liters per hour per kilogram (L/h/kg) | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
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| Secondary | Stage 2: Clearance (CL) of SAGE-547 | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. | PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2. | Posted | Mean | Standard Deviation | L/h/kg | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
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| Secondary | Stage 1: Terminal Half-Life (t½) of SAGE-547 | Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium. | PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Median | Full Range | hours | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours |
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| Secondary | Stage 2: Terminal Half-Life (t½) of SAGE-547 | Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium. | PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation. | Posted | Median | Full Range | hours | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion |
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | Stage 1: Placebo | Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1) or on Day 10 of Stage 1 (TP 2). | 0 | 25 | 0 | 25 | 3 | 25 |
| EG002 | Stage 2: SAGE-547 | Participants who completed Stage 1 received a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2. | 0 | 17 | 0 | 17 | 8 | 17 |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
| Suicidal Behavior: Actual Attempt: Pre-infusion |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 12-hour Follow-up |
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| CFB at 12-hour Follow-up |
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| CFB at 12-hour Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 12-hours Follow-up |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 8 Hours |
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| CFB at 12 Hours |
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| CFB at 2 Hours |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 3 Hours |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 3 Hours |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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| CFB at 4 Hours |
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| CFB at 6 Hours |
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| CFB at 8 Hours |
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| CFB at 10 Hours |
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| CFB at 12 Hours |
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| CFB at 12-hour Follow-up |
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| CFB at 2 Hours |
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| CFB at 3 Hours |
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| CFB at 4 Hours |
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| CFB at 5 Hours |
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| CFB at 6 Hours |
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| CFB at 7 Hours |
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| CFB at 8 Hours |
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| CFB at 9 Hours |
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| CFB at 10 Hours |
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| CFB at 11 Hours |
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| CFB at 12 Hours |
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| CFB at 14 Hours |
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| CFB at 24 Hours |
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