Parkinson Disease
Conditions
Keywords
Parkinson's
Brief summary
This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.
Detailed description
Part A of the study is an open-label design with dosing of Levodopa for 3 days followed by SAGE-217 for 4 days. Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an adjunct to antiparkinsonian agent(s). This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Interventions
DRUGSAGE-217
DRUGLevodopa
Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).
DRUGAntiparkinsonian Agent(s)
Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 2 or Stage 3) with a duration of less than 7 years prior to screening \[Part A\] * Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 1-4, assessed during the on period) \[Part B\] * Participant is on a stable dose (at least 1 month prior to baseline visit) of an antiparkinsonian agent and is willing to remain on this dose for the duration of the study
Exclusion criteria
* Participant has early (Hoehn and Yahr Stage 1) or advanced (Hoehn and Yahr Stage 4 or Stage 5) Parkinson's Disease \[Part A\] * Participant has advanced (Hoehn and Yahr Stage 5) Parkinson's Disease \[Part B\] * Participant with presence of drug-induced parkinsonism, metabolic identified neurogenetic disorders, encephalitis, or other atypical Parkinsonian syndromes * Participant with medical history of electroconvulsive therapy or stereotaxic brain surgery for Parkinson's Disease * Participant with medical history of suicide attempt within 2 years of screening or current suicidal ideation * Participant with medical history of impulse control disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | Day 1 to Day 14 | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With TEAEs, Graded by Severity - Part A | Day 1 to Day 14 | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with an inability to perform normal activities). The analysis was performed in participants included in Part A of the study. |
| Change From Baseline (CFB) in Basophils - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%). |
| CFB in Eosinophils - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Eosinophils to Leukocytes Ratio (%) - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Erythrocytes - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Hematocrit - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Hemoglobin - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Leukocytes - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Lymphocytes - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Lymphocytes to Leukocytes Ratio (%) - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Monocytes - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Monocytes to Leukocytes Ratio (%) - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Neutrophils- Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Neutrophils to Leukocytes Ratio (%) - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Platelets - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Reticulocytes - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Activated Partial Thromboplastin Time - Part A | Day 1 to Day 14 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Prothrombin International Normalized Ratio - Part A | Day 1 to Day 14 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Prothrombin Time - Part A | Day 1 to Day 14 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Alanine Aminotransferase - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Albumin - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Alkaline Phosphatase - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Aspartate Aminotransferase - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Bicarbonate - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Bilirubin - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Calcium - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Chloride - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Creatinine - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Lipase - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Magnesium - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Phosphate - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Potassium - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Protein - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Sodium - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Urate - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Urea Nitrogen - Part A | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Specific Gravity - Part A | Day 1 to Day 14 | Urinalysis measures included specific gravity and potential of hydrogen (pH). Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in pH - Part A | Day 1 to Day 14 | Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study. |
| CFB in Temperature - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Heart Rate - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Respiratory Rate - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Supine Systolic Blood Pressure - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Standing Systolic Blood Pressure - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Supine Diastolic Blood Pressure - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Standing Diastolic Blood Pressure - Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Pulse Oximetry- Part A | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Aggregate PR Interval - Part A | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Aggregate RR Interval - Part A | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Aggregate QT Interval - Part A | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Aggregate QRS Duration - Part A | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Aggregate QTcF Interval - Part A | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| CFB in Stanford Sleepiness Scale (SSS) Score - Part A | Day 1 to Day 14 | The SSS was 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 one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A | Day 1 to Day 14 | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part A of the study. |
| CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14 | The modified MDS-UPDRS included 4 scales, with various subscales. Each item was rated from 0 (normal) to 4 (severe). The scales were Part I: nonmotor experiences of daily living (13 items); Part II: motor experiences of daily living (13 items); Part III: motor examination (33 scores based on 18 items \[several with right, left or other body distribution scores\]); and Part IV: motor complications (6 items). The Part II/III tremor score was calculated as the sum of 5 individual tremor item scores from Part II and Part III. The total score range for Part II/III is 0 to 44. Lower scores represent less symptom severity and higher scores represent more symptom severity. Baseline is the last measurement taken before the first dose of study drug. A negative change from baseline indicates an improvement in symptom severity. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CFB in Aggregate QRS Duration - Part B | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| MDS-UPDRS Part III Total Score - Part A | Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14 | Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores indicate less symptom severity. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B | Day 1 to Day 14 | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part B of the study. |
| CFB in Aggregate QTcF Interval - Part B | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in the MDS-UPDRS Part III Total Score - Part B | Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14 | Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of the individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores represent less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in the MDS-UPDRS Part I Total Score - Part B | Baseline, Day 7 (12 hours postdose), Day 14 | Part I of the MDS-UPDRS assessed 13 nonmotor experiences of daily living categories. Part I total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in the MDS-UPDRS Part II Total Score - Part B | Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14 | Part II of the MDS-UPDRS assessed 13 categories of motor experiences of daily living: speech, salivation and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, car, or deep chair, walking and balance, and freezing. The Part II total score was calculated as the sum of the individual item scores from these categories. The total score range for Part II is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in the MDS-UPDRS Part I-IV Total Score - Part B | Baseline, Day 7 (12 hours postdose), Day 14 | The MDS-UPDRS assesses nonmotor experiences, motor experiences, motor skills, and motor complication categories. The MDS-UPDRS Part I-IV total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I-IV is 0 to 260. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With TEAEs - Part B | Day 1 to Day 14 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With TEAEs, Graded by Severity - Part B | Day 1 to Day 14 | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study. |
| CFB in Basophils - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Basophils to Leukocytes Ratio (%) - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Eosinophils - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Eosinophils to Leukocytes Ratio (%) - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Erythrocytes - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Hematocrit - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Hemoglobin - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Leukocytes - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Lymphocytes - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Lymphocytes to Leukocytes Ratio (%) - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Monocytes - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Monocytes to Leukocytes Ratio (%) - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Neutrophils - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Neutrophils to Leukocytes Ratio (%) - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Platelets - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Reticulocytes - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B | Day 1 to Day 14 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| CFB in Activated Partial Thromboplastin Time - Part B | Day 1 to Day 14 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Prothrombin International Normalized Ratio - Part B | Day 1 to Day 14 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Prothrombin Time - Part B | Day 1 to Day 14 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Alanine Aminotransferase - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Albumin - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Alkaline Phosphatase - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Aspartate Aminotransferase - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Bicarbonate - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Bilirubin - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Calcium - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Chloride - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Creatinine - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Lipase - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Magnesium - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Phosphate - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Potassium - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Protein - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Sodium - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Urate - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Urea Nitrogen - Part B | Day 1 to Day 14 | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Specific Gravity - Part B | Day 1 to Day 14 | Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in pH - Part B | Day 1 to Day 14 | Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Temperature - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Heart Rate - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Respiratory Rate - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Supine Systolic Blood Pressure - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Standing Systolic Blood Pressure - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Supine Diastolic Blood Pressure - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Standing Diastolic Blood Pressure - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Pulse Oximetry - Part B | Day 1 to Day 14 | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in ECG Mean Heart Rate - Part B | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Aggregate PR Interval - Part B | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Aggregate RR Interval - Part B | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
| CFB in Aggregate QT Interval - Part B | Day 1 to Day 14 | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 9 sites in the United States and took part in the study which ran from 30 November 2016 to 11 September 2017.
Participants by arm
| Arm | Count |
|---|---|
| Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. | 15 |
| Part B: Antiparkinsonian Agent(s) + SAGE-217 Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Part B: Antiparkinsonian Agent(s) + SAGE-217 | Total | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 7.76 | 64.5 years STANDARD_DEVIATION 7.17 | 63.9 years STANDARD_DEVIATION 6.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 9 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 20 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 4 / 15 | 14 / 14 | 2 / 15 | 8 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 14 | 0 / 14 |
Outcome results
Primary
CFB in Activated Partial Thromboplastin Time - Part A
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part A | CFB at Day 8 (Follow-up) | -0.10 seconds (sec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part A | Baseline | 24.80 seconds (sec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part A | CFB at Day 4 (SAGE-217) | 0.20 seconds (sec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part A | CFB at Day 6 (SAGE-217) | -0.25 seconds (sec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part A | CFB at Day 14 (Follow-up) | -1.10 seconds (sec) |
Primary
CFB in Aggregate PR Interval - Part A
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | Baseline | 158.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 3 (L/C): Predose | 2.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 4 (SAGE-217): Predose | -2.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -2.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | -8.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 5 (SAGE-217): Predose | -1.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -6.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -1.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 6 (SAGE-217): Predose | -3.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -5.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | Day 6 (SAGE-217): 12 Hours Postdose | -1.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 7 (SAGE-217): Predose | -1.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -2.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | -2.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 8 (Follow-up) | -2.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part A | CFB at Day 14 (Follow-up) | -8.0 milliseconds (msec) |
Primary
CFB in Aggregate QRS Duration - Part A
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | Baseline | 88.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 3 (L/C): Predose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 4 (SAGE-217): Predose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 5 (SAGE-217): Predose | -2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 6 (SAGE-217): Predose | -2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | Day 6 (SAGE-217): 12 Hours Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 7 (SAGE-217): Predose | -2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 8 (Follow-up) | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part A | CFB at Day 14 (Follow-up) | 3.0 msec |
Primary
CFB in Aggregate QTcF Interval - Part A
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 6 (SAGE-217): Predose | 4.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | Baseline | 419.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 3 (L/C): Predose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 4 (SAGE-217): Predose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 6.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 5 (SAGE-217): Predose | -3.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -7.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | 0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | Day 6 (SAGE-217): 12 hours postdose | -2.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 7 (SAGE-217): Predose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | -2.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 8 (Follow-up) | -0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part A | CFB at Day 14 (Follow-up) | -7.0 msec |
Primary
CFB in Aggregate QT Interval - Part A
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | Baseline | 406.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 3 (L/C): Predose | -4.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 4 (SAGE-217): Predose | -4.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -9.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | -15.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 5 (SAGE-217): Predose | -8.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -12.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -22.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 6 (SAGE-217): Predose | -4.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -9.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | Day 6 (SAGE-217): 12 Hours Postdose | -13.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 7 (SAGE-217): Predose | -12.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -13.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | -23.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 8 (Follow-up) | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part A | CFB at Day 14 (Follow-up) | -16.0 msec |
Primary
CFB in Aggregate RR Interval - Part A
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | Baseline | 950.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 3 (L/C): Predose | -32.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 4 (SAGE-217): Predose | -43.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -99.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | -98.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 5 (SAGE-217): Predose | -56.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -102.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -133.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 6 (SAGE-217): Predose | -65.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -63.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | Day 6 (SAGE-217): 12 Hours Postdose | -113.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 7 (SAGE-217): Predose | -76.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -104.5 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | -120.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 8 (Follow-up) | -10.0 milliseconds (msec) |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part A | CFB at Day 14 (Follow-up) | -86.0 milliseconds (msec) |
Primary
CFB in Alanine Aminotransferase - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part A | CFB at Day 4 (SAGE-217) | 15.3 units per liter (U/L) | Standard Deviation 11.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part A | CFB at Day 6 (SAGE-217) | 13.9 units per liter (U/L) | Standard Deviation 11.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part A | Baseline | 15.8 units per liter (U/L) | Standard Deviation 8.12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part A | CFB at Day 8 (Follow-up) | 7.2 units per liter (U/L) | Standard Deviation 13.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part A | CFB at Day 14 (Follow-up) | 2.3 units per liter (U/L) | Standard Deviation 9.24 |
Primary
CFB in Albumin - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part A | Baseline | 43.2 g/L | Standard Deviation 1.7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part A | CFB at Day 4 (SAGE-217) | -1.2 g/L | Standard Deviation 1.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part A | CFB at Day 6 (SAGE-217) | -0.4 g/L | Standard Deviation 2.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part A | CFB at Day 8 (Follow-up) | -0.1 g/L | Standard Deviation 2.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part A | CFB at Day 14 (Follow-up) | -0.3 g/L | Standard Deviation 2.35 |
Primary
CFB in Alkaline Phosphatase - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part A | Baseline | 80.6 U/L | Standard Deviation 14.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part A | CFB at Day 4 (SAGE-217) | -1.7 U/L | Standard Deviation 9.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part A | CFB at Day 6 (SAGE-217) | -2.4 U/L | Standard Deviation 4.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part A | CFB at Day 8 (Follow-up) | -0.5 U/L | Standard Deviation 4.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part A | CFB at Day 14 (Follow-up) | 0.0 U/L | Standard Deviation 8.06 |
Primary
CFB in Aspartate Aminotransferase - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part A | Baseline | 23.2 U/L | Standard Deviation 7.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part A | CFB at Day 4 (SAGE-217) | -0.4 U/L | Standard Deviation 6.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part A | CFB at Day 6 (SAGE-217) | -2.4 U/L | Standard Deviation 4.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part A | CFB at Day 8 (Follow-up) | -1.0 U/L | Standard Deviation 5.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part A | CFB at Day 14 (Follow-up) | 1.8 U/L | Standard Deviation 5.16 |
Primary
CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Baseline | 0.8 percentage | Standard Deviation 0.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | CFB at Day 4 (SAGE-217) | 0.1 percentage | Standard Deviation 0.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | CFB at Day 6 (SAGE-217) | 0.3 percentage | Standard Deviation 0.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | CFB at Day 8 (Follow-up) | 0.0 percentage | Standard Deviation 0.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | CFB at Day 14 (Follow-up) | 0.1 percentage | Standard Deviation 0.35 |
Primary
CFB in Bicarbonate - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part A | Baseline | 22.4 millimoles per liter (mmol/L) | Standard Deviation 2.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part A | CFB at Day 4 (SAGE-217) | -0.9 millimoles per liter (mmol/L) | Standard Deviation 2.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part A | CFB at Day 6 (SAGE-217) | 0.3 millimoles per liter (mmol/L) | Standard Deviation 2.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part A | CFB at Day 8 (Follow-up) | -0.1 millimoles per liter (mmol/L) | Standard Deviation 2.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part A | CFB at Day 14 (Follow-up) | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.26 |
Primary
CFB in Bilirubin - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part A | Baseline | 6.082 micromoles per liter (umol/L) | Standard Deviation 3.8041 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part A | CFB at Day 4 (SAGE-217) | -0.029 micromoles per liter (umol/L) | Standard Deviation 3.4758 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part A | CFB at Day 6 (SAGE-217) | 0.949 micromoles per liter (umol/L) | Standard Deviation 3.8554 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part A | CFB at Day 8 (Follow-up) | 1.545 micromoles per liter (umol/L) | Standard Deviation 3.5965 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part A | CFB at Day 14 (Follow-up) | 0.543 micromoles per liter (umol/L) | Standard Deviation 3.7159 |
Primary
CFB in Calcium - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part A | Baseline | 2.342 mmol/L | Standard Deviation 0.0588 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part A | CFB at Day 4 (SAGE-217) | -0.030 mmol/L | Standard Deviation 0.0734 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part A | CFB at Day 6 (SAGE-217) | 0.007 mmol/L | Standard Deviation 0.0779 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part A | CFB at Day 8 (Follow-up) | -0.014 mmol/L | Standard Deviation 0.0711 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part A | CFB at Day 14 (Follow-up) | -0.015 mmol/L | Standard Deviation 0.0842 |
Primary
CFB in Chloride - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part A | Baseline | 100.1 mmol/L | Standard Deviation 2.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part A | CFB at Day 4 (SAGE-217) | 1.6 mmol/L | Standard Deviation 1.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part A | CFB at Day 6 (SAGE-217) | 1.1 mmol/L | Standard Deviation 2.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part A | CFB at Day 8 (Follow-up) | 0.5 mmol/L | Standard Deviation 2.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part A | CFB at Day 14 (Follow-up) | 0.3 mmol/L | Standard Deviation 1.83 |
Primary
CFB in Creatinine - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part A | Baseline | 73.254 umol/L | Standard Deviation 17.796 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part A | CFB at Day 4 (SAGE-217) | 2.399 umol/L | Standard Deviation 8.6574 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part A | CFB at Day 6 (SAGE-217) | 4.104 umol/L | Standard Deviation 9.4424 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part A | CFB at Day 8 (Follow-up) | 4.420 umol/L | Standard Deviation 10.9866 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part A | CFB at Day 14 (Follow-up) | 0.118 umol/L | Standard Deviation 4.6761 |
Primary
CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | Baseline | 64.7 beats/min | Standard Deviation 11.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 3 (L/C): Predose | -0.5 beats/min | Standard Deviation 6.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 4 (SAGE-217): Predose | 1.3 beats/min | Standard Deviation 6.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | 6.9 beats/min | Standard Deviation 7.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 7.1 beats/min | Standard Deviation 8.89 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 5 (SAGE-217): Predose | 2.5 beats/min | Standard Deviation 5.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | 8.2 beats/min | Standard Deviation 5.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 9.0 beats/min | Standard Deviation 10.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 6 (SAGE-217): Predose | 3.7 beats/min | Standard Deviation 4.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | 5.9 beats/min | Standard Deviation 7.11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | Day 6 (SAGE-217): 12 Hours Postdose | 8.5 beats/min | Standard Deviation 5.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 7 (SAGE-217): Predose | 5.9 beats/min | Standard Deviation 8.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | 6.2 beats/min | Standard Deviation 6.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 10.7 beats/min | Standard Deviation 6.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 8 (Follow-up) | 0.9 beats/min | Standard Deviation 4.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A | CFB at Day 14 (Follow-up) | 4.7 beats/min | Standard Deviation 9.32 |
Primary
CFB in Eosinophils - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part A | Baseline | 0.17 10^9 cells/L | Standard Deviation 0.098 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part A | CFB at Day 4 (SAGE-217) | 0.07 10^9 cells/L | Standard Deviation 0.083 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part A | CFB at Day 6 (SAGE-217) | 0.04 10^9 cells/L | Standard Deviation 0.051 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part A | CFB at Day 8 (Follow-up) | 0.02 10^9 cells/L | Standard Deviation 0.073 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part A | CFB at Day 14 (Follow-up) | 0.00 10^9 cells/L | Standard Deviation 0.053 |
Primary
CFB in Eosinophils to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part A | Baseline | 2.9 percentage | Standard Deviation 1.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part A | CFB at Day 4 (SAGE-217) | 0.7 percentage | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part A | CFB at Day 6 (SAGE-217) | 0.3 percentage | Standard Deviation 0.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part A | CFB at Day 8 (Follow-up) | 0.0 percentage | Standard Deviation 0.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part A | CFB at Day 14 (Follow-up) | -0.3 percentage | Standard Deviation 1.11 |
Primary
CFB in Erythrocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part A | Baseline | 4.63 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.475 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part A | CFB at Day 4 (SAGE-217) | 0.01 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.266 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part A | CFB at Day 6 (SAGE-217) | 0.04 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.224 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part A | CFB at Day 8 (Follow-up) | 0.02 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.265 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part A | CFB at Day 14 (Follow-up) | -0.09 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.226 |
Primary
CFB in Heart Rate - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | 4.3 beats per minute (beats/min) | Standard Deviation 6.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | 6.0 beats per minute (beats/min) | Standard Deviation 8.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 2.6 beats per minute (beats/min) | Standard Deviation 9.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 3.6 beats per minute (beats/min) | Standard Deviation 8.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | 3.9 beats per minute (beats/min) | Standard Deviation 7.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): Predose | 1.4 beats per minute (beats/min) | Standard Deviation 5.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | 3.7 beats per minute (beats/min) | Standard Deviation 6.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | 1.6 beats per minute (beats/min) | Standard Deviation 8.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | 3.4 beats per minute (beats/min) | Standard Deviation 10.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | 0.6 beats per minute (beats/min) | Standard Deviation 6.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | 2.7 beats per minute (beats/min) | Standard Deviation 8.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | 2.1 beats per minute (beats/min) | Standard Deviation 7.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 5.1 beats per minute (beats/min) | Standard Deviation 9.7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | 5.2 beats per minute (beats/min) | Standard Deviation 6.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | 4.6 beats per minute (beats/min) | Standard Deviation 7.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): Predose | 1.5 beats per minute (beats/min) | Standard Deviation 8.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | 3.8 beats per minute (beats/min) | Standard Deviation 6.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | 4.4 beats per minute (beats/min) | Standard Deviation 9.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | 3.4 beats per minute (beats/min) | Standard Deviation 8.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | 1.3 beats per minute (beats/min) | Standard Deviation 11.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | 7.6 beats per minute (beats/min) | Standard Deviation 11.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | 4.2 beats per minute (beats/min) | Standard Deviation 9.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 8.4 beats per minute (beats/min) | Standard Deviation 9.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | 6.6 beats per minute (beats/min) | Standard Deviation 7.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | 3.7 beats per minute (beats/min) | Standard Deviation 9.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): Predose | 4.6 beats per minute (beats/min) | Standard Deviation 7.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | 2.9 beats per minute (beats/min) | Standard Deviation 7.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | 4.2 beats per minute (beats/min) | Standard Deviation 7.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | 3.2 beats per minute (beats/min) | Standard Deviation 10.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | 5.1 beats per minute (beats/min) | Standard Deviation 10.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | 4.6 beats per minute (beats/min) | Standard Deviation 11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | 4.8 beats per minute (beats/min) | Standard Deviation 10.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 5.2 beats per minute (beats/min) | Standard Deviation 9.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 5.4 beats per minute (beats/min) | Standard Deviation 10.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): Predose | 8.4 beats per minute (beats/min) | Standard Deviation 11.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | 6.0 beats per minute (beats/min) | Standard Deviation 8.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | 5.3 beats per minute (beats/min) | Standard Deviation 6.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | 3.9 beats per minute (beats/min) | Standard Deviation 12.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | 4.4 beats per minute (beats/min) | Standard Deviation 7.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 4.8 beats per minute (beats/min) | Standard Deviation 4.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 9.5 beats per minute (beats/min) | Standard Deviation 9.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | 6.7 beats per minute (beats/min) | Standard Deviation 9.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | 5.6 beats per minute (beats/min) | Standard Deviation 7.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 8 (Follow-up) | 1.8 beats per minute (beats/min) | Standard Deviation 6.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 14 (Follow-up) | 4.1 beats per minute (beats/min) | Standard Deviation 8.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | Baseline | 66.6 beats per minute (beats/min) | Standard Deviation 11.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | 2.1 beats per minute (beats/min) | Standard Deviation 5.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | 1.3 beats per minute (beats/min) | Standard Deviation 6.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | -0.5 beats per minute (beats/min) | Standard Deviation 5.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | -1.3 beats per minute (beats/min) | Standard Deviation 6.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | 0.8 beats per minute (beats/min) | Standard Deviation 7.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 0.4 beats per minute (beats/min) | Standard Deviation 7.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 5.5 beats per minute (beats/min) | Standard Deviation 6.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | 0.5 beats per minute (beats/min) | Standard Deviation 7.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | 1.4 beats per minute (beats/min) | Standard Deviation 5.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): Predose | -0.2 beats per minute (beats/min) | Standard Deviation 6.8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | 2.1 beats per minute (beats/min) | Standard Deviation 7.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | 1.9 beats per minute (beats/min) | Standard Deviation 8.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | -0.3 beats per minute (beats/min) | Standard Deviation 10.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | -0.9 beats per minute (beats/min) | Standard Deviation 5.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | 2.1 beats per minute (beats/min) | Standard Deviation 7.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 8 Hours Postdos | 3.8 beats per minute (beats/min) | Standard Deviation 7.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 3.9 beats per minute (beats/min) | Standard Deviation 8.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | 1.6 beats per minute (beats/min) | Standard Deviation 7.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | 1.2 beats per minute (beats/min) | Standard Deviation 7.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): Predose | -0.7 beats per minute (beats/min) | Standard Deviation 9.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | 4.7 beats per minute (beats/min) | Standard Deviation 6.67 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | 2.4 beats per minute (beats/min) | Standard Deviation 9.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | 1.2 beats per minute (beats/min) | Standard Deviation 7.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | 0.6 beats per minute (beats/min) | Standard Deviation 6.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | 1.7 beats per minute (beats/min) | Standard Deviation 7.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | 5.9 beats per minute (beats/min) | Standard Deviation 5.43 |
Primary
CFB in Hematocrit - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part A | Baseline | 0.434 liters per liter (L/L) | Standard Deviation 0.0444 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part A | CFB at Day 4 (SAGE-217) | 0.003 liters per liter (L/L) | Standard Deviation 0.0264 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part A | CFB at Day 6 (SAGE-217) | 0.004 liters per liter (L/L) | Standard Deviation 0.0247 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part A | CFB at Day 8 (Follow-up) | -0.002 liters per liter (L/L) | Standard Deviation 0.0285 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part A | CFB at Day 14 (Follow-up) | -0.013 liters per liter (L/L) | Standard Deviation 0.0222 |
Primary
CFB in Hemoglobin - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part A | Baseline | 142.0 grams per liter (g/L) | Standard Deviation 13.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part A | CFB at Day 4 (SAGE-217) | 0.1 grams per liter (g/L) | Standard Deviation 7.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part A | CFB at Day 6 (SAGE-217) | 1.7 grams per liter (g/L) | Standard Deviation 7.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part A | CFB at Day 8 (Follow-up) | 1.2 grams per liter (g/L) | Standard Deviation 8.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part A | CFB at Day 14 (Follow-up) | -1.9 grams per liter (g/L) | Standard Deviation 5.82 |
Primary
CFB in Leukocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part A | Baseline | 6.04 10^9 cells/L | Standard Deviation 1.139 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part A | CFB at Day 4 (SAGE-217) | -0.24 10^9 cells/L | Standard Deviation 1.085 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part A | CFB at Day 6 (SAGE-217) | 0.15 10^9 cells/L | Standard Deviation 0.536 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part A | CFB at Day 8 (Follow-up) | -0.09 10^9 cells/L | Standard Deviation 0.874 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part A | CFB at Day 14 (Follow-up) | 0.30 10^9 cells/L | Standard Deviation 0.941 |
Primary
CFB in Lipase - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part A | Baseline | 34.5 U/L | Standard Deviation 10.16 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part A | CFB at Day 4 (SAGE-217) | 16.6 U/L | Standard Deviation 22.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part A | CFB at Day 6 (SAGE-217) | 35.1 U/L | Standard Deviation 77.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part A | CFB at Day 8 (Follow-up) | 73.3 U/L | Standard Deviation 222.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part A | CFB at Day 14 (Follow-up) | -1.6 U/L | Standard Deviation 7.67 |
Primary
CFB in Lymphocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part A | Baseline | 1.70 10^9 cells/L | Standard Deviation 0.318 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part A | CFB at Day 4 (SAGE-217) | -0.02 10^9 cells/L | Standard Deviation 0.289 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part A | CFB at Day 6 (SAGE-217) | 0.07 10^9 cells/L | Standard Deviation 0.352 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part A | CFB at Day 8 (Follow-up) | 0.02 10^9 cells/L | Standard Deviation 0.286 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part A | CFB at Day 14 (Follow-up) | -0.17 10^9 cells/L | Standard Deviation 0.183 |
Primary
CFB in Lymphocytes to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part A | Baseline | 28.3 percentage | Standard Deviation 4.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part A | CFB at Day 4 (SAGE-217) | 1.0 percentage | Standard Deviation 4.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part A | CFB at Day 6 (SAGE-217) | 1.0 percentage | Standard Deviation 5.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part A | CFB at Day 8 (Follow-up) | 0.9 percentage | Standard Deviation 4.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part A | CFB at Day 14 (Follow-up) | -3.9 percentage | Standard Deviation 4.22 |
Primary
CFB in Magnesium - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part A | Baseline | 0.861 mmol/L | Standard Deviation 0.0686 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part A | CFB at Day 4 (SAGE-217) | -0.012 mmol/L | Standard Deviation 0.0409 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part A | CFB at Day 6 (SAGE-217) | 0.000 mmol/L | Standard Deviation 0.0457 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part A | CFB at Day 8 (Follow-up) | 0.015 mmol/L | Standard Deviation 0.0617 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part A | CFB at Day 14 (Follow-up) | 0.016 mmol/L | Standard Deviation 0.0618 |
Primary
CFB in Monocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part A | CFB at Day 14 (Follow-up) | 0.05 10^9 cells/L | Standard Deviation 0.064 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part A | Baseline | 0.36 10^9 cells/L | Standard Deviation 0.112 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part A | CFB at Day 4 (SAGE-217) | 0.02 10^9 cells/L | Standard Deviation 0.125 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part A | CFB at Day 6 (SAGE-217) | 0.06 10^9 cells/L | Standard Deviation 0.076 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part A | CFB at Day 8 (Follow-up) | 0.02 10^9 cells/L | Standard Deviation 0.101 |
Primary
CFB in Monocytes to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part A | Baseline | 6.1 percentage | Standard Deviation 1.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part A | CFB at Day 4 (SAGE-217) | 0.2 percentage | Standard Deviation 1.48 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part A | CFB at Day 6 (SAGE-217) | 0.6 percentage | Standard Deviation 1.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part A | CFB at Day 8 (Follow-up) | 0.5 percentage | Standard Deviation 1.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part A | CFB at Day 14 (Follow-up) | 0.3 percentage | Standard Deviation 1.22 |
Primary
CFB in Neutrophils- Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils- Part A | Baseline | 3.79 10^9 cells/L | Standard Deviation 0.861 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils- Part A | CFB at Day 4 (SAGE-217) | -0.27 10^9 cells/L | Standard Deviation 0.848 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils- Part A | CFB at Day 6 (SAGE-217) | -0.03 10^9 cells/L | Standard Deviation 0.599 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils- Part A | CFB at Day 8 (Follow-up) | -0.17 10^9 cells/L | Standard Deviation 0.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils- Part A | CFB at Day 14 (Follow-up) | 0.44 10^9 cells/L | Standard Deviation 0.861 |
Primary
CFB in Neutrophils to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part A | Baseline | 62.5 percentage | Standard Deviation 4.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part A | CFB at Day 4 (SAGE-217) | -2.4 percentage | Standard Deviation 4.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part A | CFB at Day 6 (SAGE-217) | -2.4 percentage | Standard Deviation 5.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part A | CFB at Day 8 (Follow-up) | -2.2 percentage | Standard Deviation 4.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part A | CFB at Day 14 (Follow-up) | 3.6 percentage | Standard Deviation 4.64 |
Primary
CFB in Phosphate - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part A | Baseline | 1.098 mmol/L | Standard Deviation 0.1189 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part A | CFB at Day 4 (SAGE-217) | 0.035 mmol/L | Standard Deviation 0.1413 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part A | CFB at Day 6 (SAGE-217) | 0.076 mmol/L | Standard Deviation 0.1645 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part A | CFB at Day 8 (Follow-up) | 0.083 mmol/L | Standard Deviation 0.1513 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part A | CFB at Day 14 (Follow-up) | -0.034 mmol/L | Standard Deviation 0.1698 |
Primary
CFB in pH - Part A
Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part A | Baseline | 5.87 pH | Standard Deviation 0.915 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part A | CFB at Day 4 (SAGE-217) | 0.18 pH | Standard Deviation 0.973 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part A | CFB at Day 7 (SAGE-217) | -0.11 pH | Standard Deviation 0.881 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part A | CFB at Day 14 (Follow-up) | -0.07 pH | Standard Deviation 0.884 |
Primary
CFB in Platelets - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part A | Baseline | 218.9 10^9 cells/L | Standard Deviation 62 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part A | CFB at Day 4 (SAGE-217) | 6.6 10^9 cells/L | Standard Deviation 27.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part A | CFB at Day 6 (SAGE-217) | 6.8 10^9 cells/L | Standard Deviation 33.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part A | CFB at Day 8 (Follow-up) | 7.8 10^9 cells/L | Standard Deviation 21.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part A | CFB at Day 14 (Follow-up) | 11.5 10^9 cells/L | Standard Deviation 36.42 |
Primary
CFB in Potassium - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part A | Baseline | 4.53 mmol/L | Standard Deviation 0.326 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part A | CFB at Day 4 (SAGE-217) | -0.14 mmol/L | Standard Deviation 0.323 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part A | CFB at Day 6 (SAGE-217) | -0.08 mmol/L | Standard Deviation 0.309 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part A | CFB at Day 8 (Follow-up) | -0.15 mmol/L | Standard Deviation 0.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part A | CFB at Day 14 (Follow-up) | -0.08 mmol/L | Standard Deviation 0.446 |
Primary
CFB in Protein - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part A | Baseline | 69.4 g/L | Standard Deviation 3.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part A | CFB at Day 4 (SAGE-217) | -2.3 g/L | Standard Deviation 4.12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part A | CFB at Day 6 (SAGE-217) | -1.5 g/L | Standard Deviation 3.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part A | CFB at Day 8 (Follow-up) | -0.4 g/L | Standard Deviation 3.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part A | CFB at Day 14 (Follow-up) | -1.1 g/L | Standard Deviation 4.33 |
Primary
CFB in Prothrombin International Normalized Ratio - Part A
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part A | CFB at Day 6 (SAGE-217) | -0.03 ratio | Standard Deviation 0.065 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part A | Baseline | 1.04 ratio | Standard Deviation 0.065 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part A | CFB at Day 4 (SAGE-217) | 0.01 ratio | Standard Deviation 0.108 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part A | CFB at Day 8 (Follow-up) | 0.05 ratio | Standard Deviation 0.243 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part A | CFB at Day 14 (Follow-up) | 0.01 ratio | Standard Deviation 0.155 |
Primary
CFB in Prothrombin Time - Part A
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part A | Baseline | 10.70 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part A | CFB at Day 4 (SAGE-217) | 0.00 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part A | CFB at Day 6 (SAGE-217) | 0.00 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part A | CFB at Day 8 (Follow-up) | 0.10 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part A | CFB at Day 14 (Follow-up) | -0.10 sec |
Primary
CFB in Pulse Oximetry- Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -0.4 percentage | Standard Deviation 1.7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | Baseline | 96.9 percentage | Standard Deviation 2.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 1 Hour Postdose | -0.3 percentage | Standard Deviation 1.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 2 Hours Postdose | 0.2 percentage | Standard Deviation 1.42 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 3 Hours Postdose | 0.2 percentage | Standard Deviation 1.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 4 Hours Postdose | 0.1 percentage | Standard Deviation 2.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 6 Hours Postdose | -0.2 percentage | Standard Deviation 1.42 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 8 Hours Postdose | -0.1 percentage | Standard Deviation 1.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 12 Hours Postdose | -0.1 percentage | Standard Deviation 1.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 14 Hours Postdose | -0.4 percentage | Standard Deviation 1.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 1 (L/C): 16 Hours Postdose | -0.7 percentage | Standard Deviation 2.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): Predose | -0.6 percentage | Standard Deviation 1.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 1 Hour Postdose | -0.4 percentage | Standard Deviation 2.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 2 Hours Postdose | -0.4 percentage | Standard Deviation 1.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 3 Hours Postdose | -0.2 percentage | Standard Deviation 0.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 4 Hours Postdose | -0.7 percentage | Standard Deviation 2.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 6 Hours Postdose | -0.5 percentage | Standard Deviation 2.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 8 Hours Postdose | 0.4 percentage | Standard Deviation 1.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 12 Hours Postdose | -0.1 percentage | Standard Deviation 1.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 14 Hours Postdose | -0.6 percentage | Standard Deviation 1.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 2 (L/C): 16 Hours Postdose | -0.2 percentage | Standard Deviation 1.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): Predose | -0.5 percentage | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 1 Hour Postdose | -1.1 percentage | Standard Deviation 1.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 3 Hours Postdose | -0.3 percentage | Standard Deviation 1.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 4 Hours Postdose | -0.1 percentage | Standard Deviation 1.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 6 Hours Postdose | 0.3 percentage | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 8 Hours Postdose | -0.1 percentage | Standard Deviation 1.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 0.0 percentage | Standard Deviation 1.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 0.4 percentage | Standard Deviation 1.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 3 (L/C): 16 Hours Postdose | -0.2 percentage | Standard Deviation 1.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): Predose | 0.0 percentage | Standard Deviation 0.96 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -1.6 percentage | Standard Deviation 3.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | -0.7 percentage | Standard Deviation 2.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | -0.1 percentage | Standard Deviation 1.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | -0.4 percentage | Standard Deviation 1.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | -0.4 percentage | Standard Deviation 1.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | -0.4 percentage | Standard Deviation 1.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | -0.1 percentage | Standard Deviation 1.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | -0.2 percentage | Standard Deviation 1.42 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | -0.3 percentage | Standard Deviation 1.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): Predose | 0.2 percentage | Standard Deviation 1.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -1.3 percentage | Standard Deviation 2.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -1.2 percentage | Standard Deviation 2.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | 0.1 percentage | Standard Deviation 1.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | 0.0 percentage | Standard Deviation 1.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | -0.2 percentage | Standard Deviation 1.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | -0.1 percentage | Standard Deviation 1.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -0.4 percentage | Standard Deviation 2.56 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | -0.6 percentage | Standard Deviation 2.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | -1.1 percentage | Standard Deviation 2.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): Predose | -0.5 percentage | Standard Deviation 1.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -1.1 percentage | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | 0.1 percentage | Standard Deviation 2.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | -0.9 percentage | Standard Deviation 2.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | -0.4 percentage | Standard Deviation 2.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | 0.1 percentage | Standard Deviation 2.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | 0.0 percentage | Standard Deviation 1.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | 0.0 percentage | Standard Deviation 1.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | -0.4 percentage | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 0.1 percentage | Standard Deviation 2.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): Predose | 0.3 percentage | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -1.4 percentage | Standard Deviation 2.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | -0.4 percentage | Standard Deviation 2.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | -0.5 percentage | Standard Deviation 2.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | 0.4 percentage | Standard Deviation 1.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | 0.3 percentage | Standard Deviation 0.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 0.3 percentage | Standard Deviation 1.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 0.3 percentage | Standard Deviation 1.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | 0.3 percentage | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | 0.2 percentage | Standard Deviation 1.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 8 (Follow-up) | 0.3 percentage | Standard Deviation 1.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry- Part A | CFB at Day 14 (Follow-up) | 0.5 percentage | Standard Deviation 1.77 |
Primary
CFB in Respiratory Rate - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | Baseline | 15.9 breaths per minute (breaths/min) | Standard Deviation 1.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | 0.0 breaths per minute (breaths/min) | Standard Deviation 1.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | 0.0 breaths per minute (breaths/min) | Standard Deviation 1.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 1.0 breaths per minute (breaths/min) | Standard Deviation 2.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 0.6 breaths per minute (breaths/min) | Standard Deviation 1.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | -0.2 breaths per minute (breaths/min) | Standard Deviation 2.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): Predose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.48 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | 0.0 breaths per minute (breaths/min) | Standard Deviation 1.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 2.32 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 2.62 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): Predose | -0.4 breaths per minute (breaths/min) | Standard Deviation 1.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 2.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 2.11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 2.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | 0.0 breaths per minute (breaths/min) | Standard Deviation 2.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): Predose | 0.9 breaths per minute (breaths/min) | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 2.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | -0.4 breaths per minute (breaths/min) | Standard Deviation 2.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | 0.7 breaths per minute (breaths/min) | Standard Deviation 1.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 0.9 breaths per minute (breaths/min) | Standard Deviation 1.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 2.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): Predose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 2.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -0.4 breaths per minute (breaths/min) | Standard Deviation 2.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | 1.0 breaths per minute (breaths/min) | Standard Deviation 1.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): Predose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -0.6 breaths per minute (breaths/min) | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 2.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | 1.0 breaths per minute (breaths/min) | Standard Deviation 1.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 2.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): Predose | 0.0 breaths per minute (breaths/min) | Standard Deviation 1.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | 0.9 breaths per minute (breaths/min) | Standard Deviation 1.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | 0.6 breaths per minute (breaths/min) | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 1.4 breaths per minute (breaths/min) | Standard Deviation 2.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | 0.7 breaths per minute (breaths/min) | Standard Deviation 2.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 8 (Follow-up) | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part A | CFB at Day 14 (Follow-up) | 0.9 breaths per minute (breaths/min) | Standard Deviation 1.83 |
Primary
CFB in Reticulocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part A | Baseline | 64.6 10^9 cells/L | Standard Deviation 20.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part A | CFB at Day 4 (SAGE-217) | -0.3 10^9 cells/L | Standard Deviation 17.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part A | CFB at Day 6 (SAGE-217) | 0.3 10^9 cells/L | Standard Deviation 19.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part A | CFB at Day 8 (Follow-up) | 0.2 10^9 cells/L | Standard Deviation 20.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part A | CFB at Day 14 (Follow-up) | 0.3 10^9 cells/L | Standard Deviation 14.1 |
Primary
CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A | Baseline | 1.41 percentage | Standard Deviation 0.442 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A | CFB at Day 4 (SAGE-217) | 0.00 percentage | Standard Deviation 0.349 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A | CFB at Day 6 (SAGE-217) | -0.03 percentage | Standard Deviation 0.409 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A | CFB at Day 8 (Follow-up) | 0.00 percentage | Standard Deviation 0.424 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A | CFB at Day 14 (Follow-up) | 0.03 percentage | Standard Deviation 0.315 |
Primary
CFB in Sodium - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part A | Baseline | 140.0 mmol/L | Standard Deviation 1.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part A | CFB at Day 4 (SAGE-217) | 0.8 mmol/L | Standard Deviation 2.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part A | CFB at Day 6 (SAGE-217) | 1.3 mmol/L | Standard Deviation 1.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part A | CFB at Day 8 (Follow-up) | 0.7 mmol/L | Standard Deviation 2.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part A | CFB at Day 14 (Follow-up) | 0.5 mmol/L | Standard Deviation 1.85 |
Primary
CFB in Specific Gravity - Part A
Urinalysis measures included specific gravity and potential of hydrogen (pH). Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part A | Baseline | 1.018 ratio | Standard Deviation 0.0049 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part A | CFB at Day 4 (SAGE-217) | -0.001 ratio | Standard Deviation 0.0062 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part A | CFB at Day 7 (SAGE-217) | 0.000 ratio | Standard Deviation 0.0039 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part A | CFB at Day 14 (Follow-up) | 0.002 ratio | Standard Deviation 0.0059 |
Primary
CFB in Standing Diastolic Blood Pressure - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | Baseline | 76.7 mmHg | Standard Deviation 10.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | 0.4 mmHg | Standard Deviation 8.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | -2.9 mmHg | Standard Deviation 7.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | 0.7 mmHg | Standard Deviation 7.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | 2.3 mmHg | Standard Deviation 5.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | 0.9 mmHg | Standard Deviation 10.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 3.1 mmHg | Standard Deviation 7.16 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 2.6 mmHg | Standard Deviation 7.04 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | 1.3 mmHg | Standard Deviation 7.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | 1.6 mmHg | Standard Deviation 7.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): Predose | 4.0 mmHg | Standard Deviation 8.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | 1.6 mmHg | Standard Deviation 7.89 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | 1.1 mmHg | Standard Deviation 12.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | 1.1 mmHg | Standard Deviation 8.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | 3.8 mmHg | Standard Deviation 10.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | 0.3 mmHg | Standard Deviation 12.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | 1.6 mmHg | Standard Deviation 10.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 4.3 mmHg | Standard Deviation 6.8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | 3.7 mmHg | Standard Deviation 5.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | 0.1 mmHg | Standard Deviation 5.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): Predose | 4.4 mmHg | Standard Deviation 7.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | -1.1 mmHg | Standard Deviation 9.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -0.9 mmHg | Standard Deviation 6.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | -1.7 mmHg | Standard Deviation 12.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | -0.7 mmHg | Standard Deviation 11.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | -0.6 mmHg | Standard Deviation 9.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | -1.0 mmHg | Standard Deviation 11.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 0.6 mmHg | Standard Deviation 7.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 1.8 mmHg | Standard Deviation 9.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | 3.8 mmHg | Standard Deviation 10.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): Predose | 4.6 mmHg | Standard Deviation 9.11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | 1.8 mmHg | Standard Deviation 8.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | 2.4 mmHg | Standard Deviation 6.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | 5.6 mmHg | Standard Deviation 7.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | 3.7 mmHg | Standard Deviation 7.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | 0.3 mmHg | Standard Deviation 8.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | 1.9 mmHg | Standard Deviation 7.88 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 4.8 mmHg | Standard Deviation 11.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | 1.9 mmHg | Standard Deviation 10.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | 2.8 mmHg | Standard Deviation 9.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): Predose | 2.6 mmHg | Standard Deviation 5.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -2.5 mmHg | Standard Deviation 5.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -0.8 mmHg | Standard Deviation 6.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | 3.8 mmHg | Standard Deviation 6.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | 2.7 mmHg | Standard Deviation 6.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | 1.6 mmHg | Standard Deviation 6.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | 0.1 mmHg | Standard Deviation 8.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 0.2 mmHg | Standard Deviation 9.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | 0.4 mmHg | Standard Deviation 9.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | 0.8 mmHg | Standard Deviation 9.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): Predose | -0.4 mmHg | Standard Deviation 8.56 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | 0.9 mmHg | Standard Deviation 7.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | 0.8 mmHg | Standard Deviation 7.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | 2.0 mmHg | Standard Deviation 10.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | 1.2 mmHg | Standard Deviation 8.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | 1.6 mmHg | Standard Deviation 7.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | 2.3 mmHg | Standard Deviation 9.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | 0.7 mmHg | Standard Deviation 9.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 3.1 mmHg | Standard Deviation 8.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 2.8 mmHg | Standard Deviation 11.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): Predose | 2.4 mmHg | Standard Deviation 8.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | 0.3 mmHg | Standard Deviation 8.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | -2.0 mmHg | Standard Deviation 7.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | -0.2 mmHg | Standard Deviation 6.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | -1.4 mmHg | Standard Deviation 9.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | -0.9 mmHg | Standard Deviation 7.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 2.7 mmHg | Standard Deviation 6.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 2.0 mmHg | Standard Deviation 10.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | 2.9 mmHg | Standard Deviation 11.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | 1.1 mmHg | Standard Deviation 9.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 8 (Follow-up) | 2.1 mmHg | Standard Deviation 7.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part A | CFB at Day 14 (Follow-up) | 1.5 mmHg | Standard Deviation 8.06 |
Primary
CFB in Standing Systolic Blood Pressure - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 4.3 mmHg | Standard Deviation 10.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 7.6 mmHg | Standard Deviation 17.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | 2.9 mmHg | Standard Deviation 10.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | -2.7 mmHg | Standard Deviation 9.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): Predose | 1.0 mmHg | Standard Deviation 11.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | -2.9 mmHg | Standard Deviation 10.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | -3.4 mmHg | Standard Deviation 11.56 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | -5.1 mmHg | Standard Deviation 9.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | 0.0 mmHg | Standard Deviation 10.12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | -3.4 mmHg | Standard Deviation 8.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | -0.6 mmHg | Standard Deviation 10.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 5.6 mmHg | Standard Deviation 16.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | -4.7 mmHg | Standard Deviation 10 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | Baseline | 124.1 mmHg | Standard Deviation 12.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | -3.1 mmHg | Standard Deviation 9.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | -2.9 mmHg | Standard Deviation 11.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | 0.0 mmHg | Standard Deviation 11.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | 2.7 mmHg | Standard Deviation 13.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 8 (Follow-up) | 7.6 mmHg | Standard Deviation 9.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | 2.0 mmHg | Standard Deviation 11.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | -4.4 mmHg | Standard Deviation 10.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): Predose | -1.4 mmHg | Standard Deviation 7.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | -4.2 mmHg | Standard Deviation 8.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -4.9 mmHg | Standard Deviation 11.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | -4.4 mmHg | Standard Deviation 13.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | -6.2 mmHg | Standard Deviation 13.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | -3.2 mmHg | Standard Deviation 9.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | -3.2 mmHg | Standard Deviation 10.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 1.8 mmHg | Standard Deviation 14.56 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 0.0 mmHg | Standard Deviation 15.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | 2.2 mmHg | Standard Deviation 11.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): Predose | 3.3 mmHg | Standard Deviation 13.32 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -1.5 mmHg | Standard Deviation 14.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | -4.6 mmHg | Standard Deviation 10.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | -0.5 mmHg | Standard Deviation 11.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | -5.7 mmHg | Standard Deviation 10.04 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | -2.3 mmHg | Standard Deviation 8.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | 0.9 mmHg | Standard Deviation 9.16 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 3.3 mmHg | Standard Deviation 12.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | 0.0 mmHg | Standard Deviation 10.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | -1.3 mmHg | Standard Deviation 10.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): Predose | -0.6 mmHg | Standard Deviation 9.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -9.8 mmHg | Standard Deviation 12.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -8.3 mmHg | Standard Deviation 10.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | -3.8 mmHg | Standard Deviation 14.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | -2.4 mmHg | Standard Deviation 9.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | -2.1 mmHg | Standard Deviation 12.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | -3.3 mmHg | Standard Deviation 10.16 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 1.4 mmHg | Standard Deviation 12.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | 2.3 mmHg | Standard Deviation 17.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | 0.8 mmHg | Standard Deviation 15.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): Predose | -3.3 mmHg | Standard Deviation 12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -6.4 mmHg | Standard Deviation 10.89 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | -5.5 mmHg | Standard Deviation 9.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | -3.5 mmHg | Standard Deviation 10.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | -2.8 mmHg | Standard Deviation 8.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | 1.6 mmHg | Standard Deviation 9.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | -2.7 mmHg | Standard Deviation 12.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | -2.9 mmHg | Standard Deviation 12.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 2.5 mmHg | Standard Deviation 13.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 0.6 mmHg | Standard Deviation 19.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): Predose | -0.2 mmHg | Standard Deviation 12.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -4.0 mmHg | Standard Deviation 13.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | -4.7 mmHg | Standard Deviation 13.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | -6.0 mmHg | Standard Deviation 9.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | -5.9 mmHg | Standard Deviation 13.96 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | -2.4 mmHg | Standard Deviation 13.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 2.1 mmHg | Standard Deviation 10.8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 4.6 mmHg | Standard Deviation 14.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | 3.7 mmHg | Standard Deviation 13.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | 0.5 mmHg | Standard Deviation 11.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part A | CFB at Day 14 (Follow-up) | 3.6 mmHg | Standard Deviation 13.14 |
Primary
CFB in Stanford Sleepiness Scale (SSS) Score - Part A
The SSS was 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 one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | Baseline | 1.2 score on a scale | Standard Deviation 0.56 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | -0.1 score on a scale | Standard Deviation 0.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | -0.1 score on a scale | Standard Deviation 0.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | -0.1 score on a scale | Standard Deviation 0.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | 0.0 score on a scale | Standard Deviation 0.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | 0.0 score on a scale | Standard Deviation 0.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 0.4 score on a scale | Standard Deviation 1.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | 0.6 score on a scale | Standard Deviation 0.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | 1.0 score on a scale | Standard Deviation 0.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): Predose | 0.4 score on a scale | Standard Deviation 0.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | 0.3 score on a scale | Standard Deviation 0.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | 0.5 score on a scale | Standard Deviation 1.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | 0.3 score on a scale | Standard Deviation 0.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | 0.5 score on a scale | Standard Deviation 1.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | 0.4 score on a scale | Standard Deviation 0.96 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 0.3 score on a scale | Standard Deviation 0.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | 0.6 score on a scale | Standard Deviation 0.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | 0.7 score on a scale | Standard Deviation 0.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): Predose | 0.3 score on a scale | Standard Deviation 0.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | 0.0 score on a scale | Standard Deviation 0.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | 0.3 score on a scale | Standard Deviation 0.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | 0.3 score on a scale | Standard Deviation 1.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | 0.4 score on a scale | Standard Deviation 1.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | 0.3 score on a scale | Standard Deviation 0.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 0.4 score on a scale | Standard Deviation 1.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 1.0 score on a scale | Standard Deviation 1.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | 0.7 score on a scale | Standard Deviation 0.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): Predose | 0.3 score on a scale | Standard Deviation 0.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | 3.2 score on a scale | Standard Deviation 2.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | 2.6 score on a scale | Standard Deviation 2.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | 2.0 score on a scale | Standard Deviation 1.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | 1.2 score on a scale | Standard Deviation 1.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | 0.4 score on a scale | Standard Deviation 1.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | 1.0 score on a scale | Standard Deviation 0.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): Predose | 0.3 score on a scale | Standard Deviation 0.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | 3.8 score on a scale | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | 1.8 score on a scale | Standard Deviation 1.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | 1.1 score on a scale | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | 0.8 score on a scale | Standard Deviation 1.42 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | 0.6 score on a scale | Standard Deviation 0.96 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | 0.1 score on a scale | Standard Deviation 0.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | 0.4 score on a scale | Standard Deviation 0.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | 0.8 score on a scale | Standard Deviation 1.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): Predose | 0.1 score on a scale | Standard Deviation 0.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | 2.6 score on a scale | Standard Deviation 1.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | 1.8 score on a scale | Standard Deviation 1.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | 1.6 score on a scale | Standard Deviation 2.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | 1.1 score on a scale | Standard Deviation 1.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | 0.8 score on a scale | Standard Deviation 1.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | 0.3 score on a scale | Standard Deviation 0.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.89 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 0.4 score on a scale | Standard Deviation 0.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 0.9 score on a scale | Standard Deviation 1.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): Predose | 0.2 score on a scale | Standard Deviation 0.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 1 hour postdose | 2.0 score on a scale | Standard Deviation 1.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | 1.3 score on a scale | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | 0.7 score on a scale | Standard Deviation 1.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | 0.7 score on a scale | Standard Deviation 1.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | 0.1 score on a scale | Standard Deviation 0.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 0.2 score on a scale | Standard Deviation 0.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 0.1 score on a scale | Standard Deviation 0.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | 0.4 score on a scale | Standard Deviation 1.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | 0.4 score on a scale | Standard Deviation 1.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 8 (Follow-up) | -0.1 score on a scale | Standard Deviation 0.62 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Stanford Sleepiness Scale (SSS) Score - Part A | CFB at Day 14 (Follow-up) | -0.1 score on a scale | Standard Deviation 0.59 |
Primary
CFB in Supine Diastolic Blood Pressure - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | Baseline | 77.3 mmHg | Standard Deviation 7.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | -5.3 mmHg | Standard Deviation 6.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | -4.7 mmHg | Standard Deviation 5.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | -3.2 mmHg | Standard Deviation 6.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | -3.1 mmHg | Standard Deviation 5.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | -3.9 mmHg | Standard Deviation 9.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | -0.4 mmHg | Standard Deviation 9.04 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | -0.1 mmHg | Standard Deviation 7.89 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | -3.6 mmHg | Standard Deviation 8.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | -5.0 mmHg | Standard Deviation 10.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): Predose | 0.7 mmHg | Standard Deviation 7.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | -4.8 mmHg | Standard Deviation 9.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | -3.4 mmHg | Standard Deviation 9.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | -2.2 mmHg | Standard Deviation 11.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | -2.5 mmHg | Standard Deviation 7.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | -1.4 mmHg | Standard Deviation 10.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | -1.4 mmHg | Standard Deviation 10.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 0.9 mmHg | Standard Deviation 7.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | -1.9 mmHg | Standard Deviation 8.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | -3.4 mmHg | Standard Deviation 7.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): Predose | -0.8 mmHg | Standard Deviation 7.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | -5.1 mmHg | Standard Deviation 8.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -3.1 mmHg | Standard Deviation 8.11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | -4.3 mmHg | Standard Deviation 9.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | -5.9 mmHg | Standard Deviation 13.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | -4.1 mmHg | Standard Deviation 8.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | -3.9 mmHg | Standard Deviation 9.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | -1.0 mmHg | Standard Deviation 8.32 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | -0.9 mmHg | Standard Deviation 7.8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | -2.5 mmHg | Standard Deviation 8.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): Predose | 1.8 mmHg | Standard Deviation 7.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -1.9 mmHg | Standard Deviation 6.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | -3.6 mmHg | Standard Deviation 6.48 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | 1.5 mmHg | Standard Deviation 8.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | -0.8 mmHg | Standard Deviation 8.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | -3.6 mmHg | Standard Deviation 8.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | -1.7 mmHg | Standard Deviation 7.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 0.0 mmHg | Standard Deviation 6.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | -3.6 mmHg | Standard Deviation 8.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | -4.0 mmHg | Standard Deviation 7.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): Predose | -2.1 mmHg | Standard Deviation 8.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -5.4 mmHg | Standard Deviation 7.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -2.4 mmHg | Standard Deviation 6.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | -3.1 mmHg | Standard Deviation 6.62 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | -3.3 mmHg | Standard Deviation 6.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | -2.4 mmHg | Standard Deviation 8.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | -3.4 mmHg | Standard Deviation 7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -4.0 mmHg | Standard Deviation 9.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | -4.3 mmHg | Standard Deviation 7.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | -2.2 mmHg | Standard Deviation 10.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): Predose | -3.6 mmHg | Standard Deviation 7.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -3.7 mmHg | Standard Deviation 9.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | -2.7 mmHg | Standard Deviation 9.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | -1.8 mmHg | Standard Deviation 8.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | -1.8 mmHg | Standard Deviation 11.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | -3.9 mmHg | Standard Deviation 8.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | -1.7 mmHg | Standard Deviation 8.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | -1.0 mmHg | Standard Deviation 9.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 0.8 mmHg | Standard Deviation 7.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | -3.6 mmHg | Standard Deviation 10.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): Predose | -1.9 mmHg | Standard Deviation 6.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -5.1 mmHg | Standard Deviation 7.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | -3.5 mmHg | Standard Deviation 9.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | -2.7 mmHg | Standard Deviation 10.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | -4.5 mmHg | Standard Deviation 9.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | -4.8 mmHg | Standard Deviation 8.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | -2.2 mmHg | Standard Deviation 10.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | -1.0 mmHg | Standard Deviation 8.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | -3.5 mmHg | Standard Deviation 10.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | -4.2 mmHg | Standard Deviation 9.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 8 (Follow-up) | -3.8 mmHg | Standard Deviation 8.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part A | CFB at Day 14 (Follow-up) | -2.2 mmHg | Standard Deviation 7.22 |
Primary
CFB in Supine Systolic Blood Pressure - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | Baseline | 124.5 millimeters of mercury (mmHg) | Standard Deviation 11.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | -6.7 millimeters of mercury (mmHg) | Standard Deviation 10.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | -7.1 millimeters of mercury (mmHg) | Standard Deviation 11.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | -1.5 millimeters of mercury (mmHg) | Standard Deviation 10.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | -4.7 millimeters of mercury (mmHg) | Standard Deviation 9.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | -4.5 millimeters of mercury (mmHg) | Standard Deviation 9.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 2.4 millimeters of mercury (mmHg) | Standard Deviation 13.32 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 3.4 millimeters of mercury (mmHg) | Standard Deviation 13.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | -3.0 millimeters of mercury (mmHg) | Standard Deviation 12.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | -3.9 millimeters of mercury (mmHg) | Standard Deviation 11.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): Predose | -0.4 millimeters of mercury (mmHg) | Standard Deviation 11.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | -7.3 millimeters of mercury (mmHg) | Standard Deviation 11.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | -4.4 millimeters of mercury (mmHg) | Standard Deviation 9.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | -0.8 millimeters of mercury (mmHg) | Standard Deviation 10.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | -1.1 millimeters of mercury (mmHg) | Standard Deviation 10.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | -1.6 millimeters of mercury (mmHg) | Standard Deviation 10.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | 3.2 millimeters of mercury (mmHg) | Standard Deviation 15.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 5.9 millimeters of mercury (mmHg) | Standard Deviation 8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | 3.4 millimeters of mercury (mmHg) | Standard Deviation 9.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | 0.9 millimeters of mercury (mmHg) | Standard Deviation 10.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): Predose | 1.2 millimeters of mercury (mmHg) | Standard Deviation 8.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | -2.5 millimeters of mercury (mmHg) | Standard Deviation 10.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -7.4 millimeters of mercury (mmHg) | Standard Deviation 14.7 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | -3.1 millimeters of mercury (mmHg) | Standard Deviation 12.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | -3.7 millimeters of mercury (mmHg) | Standard Deviation 14.12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | -3.1 millimeters of mercury (mmHg) | Standard Deviation 12.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | -1.3 millimeters of mercury (mmHg) | Standard Deviation 12.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | 3.3 millimeters of mercury (mmHg) | Standard Deviation 13.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | 3.6 millimeters of mercury (mmHg) | Standard Deviation 16.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | -3.3 millimeters of mercury (mmHg) | Standard Deviation 10.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): Predose | 3.5 millimeters of mercury (mmHg) | Standard Deviation 10.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | -4.8 millimeters of mercury (mmHg) | Standard Deviation 9.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | -6.6 millimeters of mercury (mmHg) | Standard Deviation 10.8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | 2.3 millimeters of mercury (mmHg) | Standard Deviation 15.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | -1.6 millimeters of mercury (mmHg) | Standard Deviation 8.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | -3.9 millimeters of mercury (mmHg) | Standard Deviation 10.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | 2.2 millimeters of mercury (mmHg) | Standard Deviation 10.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | 3.1 millimeters of mercury (mmHg) | Standard Deviation 9.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | -3.1 millimeters of mercury (mmHg) | Standard Deviation 14.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | -2.6 millimeters of mercury (mmHg) | Standard Deviation 10.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): Predose | 0.1 millimeters of mercury (mmHg) | Standard Deviation 11.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -8.6 millimeters of mercury (mmHg) | Standard Deviation 9.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -8.1 millimeters of mercury (mmHg) | Standard Deviation 11.67 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | -5.8 millimeters of mercury (mmHg) | Standard Deviation 10.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | -0.4 millimeters of mercury (mmHg) | Standard Deviation 9.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | -2.9 millimeters of mercury (mmHg) | Standard Deviation 11.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | -3.8 millimeters of mercury (mmHg) | Standard Deviation 10.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | 1.3 millimeters of mercury (mmHg) | Standard Deviation 11.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | 1.7 millimeters of mercury (mmHg) | Standard Deviation 15.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | 0.6 millimeters of mercury (mmHg) | Standard Deviation 14.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): Predose | -5.9 millimeters of mercury (mmHg) | Standard Deviation 11.67 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | -8.6 millimeters of mercury (mmHg) | Standard Deviation 11.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | -3.8 millimeters of mercury (mmHg) | Standard Deviation 13.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | -4.1 millimeters of mercury (mmHg) | Standard Deviation 15.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | -5.6 millimeters of mercury (mmHg) | Standard Deviation 13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | -4.4 millimeters of mercury (mmHg) | Standard Deviation 10.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | -0.1 millimeters of mercury (mmHg) | Standard Deviation 12.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | -0.1 millimeters of mercury (mmHg) | Standard Deviation 12.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | 2.5 millimeters of mercury (mmHg) | Standard Deviation 10.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 1.8 millimeters of mercury (mmHg) | Standard Deviation 13.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): Predose | 1.9 millimeters of mercury (mmHg) | Standard Deviation 19.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -5.9 millimeters of mercury (mmHg) | Standard Deviation 12.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | -5.4 millimeters of mercury (mmHg) | Standard Deviation 18.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | -2.8 millimeters of mercury (mmHg) | Standard Deviation 13.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | -5.1 millimeters of mercury (mmHg) | Standard Deviation 17.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | -3.9 millimeters of mercury (mmHg) | Standard Deviation 14.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | -3.1 millimeters of mercury (mmHg) | Standard Deviation 10.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 2.9 millimeters of mercury (mmHg) | Standard Deviation 13.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | -0.6 millimeters of mercury (mmHg) | Standard Deviation 14.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | -0.2 millimeters of mercury (mmHg) | Standard Deviation 18.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 8 (Follow-up) | 1.7 millimeters of mercury (mmHg) | Standard Deviation 7.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part A | CFB at Day 14 (Follow-up) | 2.7 millimeters of mercury (mmHg) | Standard Deviation 9.5 |
Primary
CFB in Temperature - Part A
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | Baseline | 36.61 degrees Celsius (degrees C) | Standard Deviation 0.228 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 1 Hour Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 2 Hours Postdose | -0.01 degrees Celsius (degrees C) | Standard Deviation 0.205 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 3 Hours Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.236 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 4 Hours Postdose | -0.08 degrees Celsius (degrees C) | Standard Deviation 0.227 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 6 Hours Postdose | -0.06 degrees Celsius (degrees C) | Standard Deviation 0.285 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 8 Hours Postdose | 0.00 degrees Celsius (degrees C) | Standard Deviation 0.235 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 12 Hours Postdose | 0.08 degrees Celsius (degrees C) | Standard Deviation 0.412 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 14 Hours Postdose | 0.00 degrees Celsius (degrees C) | Standard Deviation 0.319 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 1 (L/C): 16 Hours Postdose | -0.01 degrees Celsius (degrees C) | Standard Deviation 0.296 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): Predose | -0.06 degrees Celsius (degrees C) | Standard Deviation 0.346 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 1 Hour Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.316 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 2 Hours Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.348 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 14 Hours Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 3 Hours Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.323 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 4 Hours Postdose | -0.07 degrees Celsius (degrees C) | Standard Deviation 0.279 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 6 Hours Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.274 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 8 Hours Postdose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.283 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 12 Hours Postdose | 0.06 degrees Celsius (degrees C) | Standard Deviation 0.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 2 (L/C): 16 Hours Postdose | -0.06 degrees Celsius (degrees C) | Standard Deviation 0.365 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): Predose | 0.09 degrees Celsius (degrees C) | Standard Deviation 0.409 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 1 Hour Postdose | -0.09 degrees Celsius (degrees C) | Standard Deviation 0.305 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 2 Hours Postdose | -0.10 degrees Celsius (degrees C) | Standard Deviation 0.277 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 3 Hours Postdose | -0.10 degrees Celsius (degrees C) | Standard Deviation 0.272 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 4 Hours Postdose | -0.03 degrees Celsius (degrees C) | Standard Deviation 0.331 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 6 Hours Postdose | -0.06 degrees Celsius (degrees C) | Standard Deviation 0.363 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 8 Hours Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.276 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 12 Hours Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.422 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 14 Hours Postdose | -0.01 degrees Celsius (degrees C) | Standard Deviation 0.372 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 3 (L/C): 16 Hours Postdose | 0.04 degrees Celsius (degrees C) | Standard Deviation 0.176 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): Predose | 0.02 degrees Celsius (degrees C) | Standard Deviation 0.208 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 1 Hour Postdose | 0.01 degrees Celsius (degrees C) | Standard Deviation 0.175 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 2 Hours Postdose | 0.08 degrees Celsius (degrees C) | Standard Deviation 0.387 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 4 Hours Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.236 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 3 Hours Postdose | -0.07 degrees Celsius (degrees C) | Standard Deviation 0.236 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 6 Hours Postdose | 0.03 degrees Celsius (degrees C) | Standard Deviation 0.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 8 Hours Postdose | -0.03 degrees Celsius (degrees C) | Standard Deviation 0.336 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 12 Hours Postdose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.333 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 14 Hours Postdose | 0.12 degrees Celsius (degrees C) | Standard Deviation 0.185 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 4 (SAGE-217): 16 Hours Postdose | 0.07 degrees Celsius (degrees C) | Standard Deviation 0.233 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): Predose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.187 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 1 Hour Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.287 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 2 Hours Postdose | -0.16 degrees Celsius (degrees C) | Standard Deviation 0.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 3 Hours Postdose | -0.17 degrees Celsius (degrees C) | Standard Deviation 0.272 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 4 Hours Postdose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.449 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 6 Hours Postdose | -0.16 degrees Celsius (degrees C) | Standard Deviation 0.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 8 Hours Postdose | -0.07 degrees Celsius (degrees C) | Standard Deviation 0.421 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 12 Hours Postdose | -0.09 degrees Celsius (degrees C) | Standard Deviation 0.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 14 Hours Postdose | -0.07 degrees Celsius (degrees C) | Standard Deviation 0.273 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 5 (SAGE-217): 16 Hours Postdose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.383 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): Predose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.359 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 12 Hours Postdose | -0.10 degrees Celsius (degrees C) | Standard Deviation 0.697 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 1 Hour Postdose | 0.02 degrees Celsius (degrees C) | Standard Deviation 0.306 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 2 Hours Postdose | -0.08 degrees Celsius (degrees C) | Standard Deviation 0.322 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 3 Hours Postdose | -0.13 degrees Celsius (degrees C) | Standard Deviation 0.322 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 4 Hours Postdose | -0.12 degrees Celsius (degrees C) | Standard Deviation 0.358 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 6 Hours Postdose | -0.09 degrees Celsius (degrees C) | Standard Deviation 0.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 8 Hours Postdose | -0.08 degrees Celsius (degrees C) | Standard Deviation 0.329 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 14 Hours Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.434 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 6 (SAGE-217): 16 Hours Postdose | 0.06 degrees Celsius (degrees C) | Standard Deviation 0.434 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): Predose | -0.13 degrees Celsius (degrees C) | Standard Deviation 0.302 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 1 Hour Postdose | -0.16 degrees Celsius (degrees C) | Standard Deviation 0.282 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 2 Hours Postdose | -0.16 degrees Celsius (degrees C) | Standard Deviation 0.407 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 3 Hours Postdose | -0.16 degrees Celsius (degrees C) | Standard Deviation 0.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 4 Hours Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.332 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 6 Hours Postdose | -0.13 degrees Celsius (degrees C) | Standard Deviation 0.252 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 8 Hours Postdose | 0.02 degrees Celsius (degrees C) | Standard Deviation 0.208 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 12 Hours Postdose | 0.06 degrees Celsius (degrees C) | Standard Deviation 0.145 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 14 Hours Postdose | -0.01 degrees Celsius (degrees C) | Standard Deviation 0.235 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 7 (SAGE-217): 16 Hours Postdose | -0.03 degrees Celsius (degrees C) | Standard Deviation 0.363 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 8 (Follow-up) | 0.4 degrees Celsius (degrees C) | Standard Deviation 0.224 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part A | CFB at Day 14 (Follow-up) | 0.07 degrees Celsius (degrees C) | Standard Deviation 0.301 |
Primary
CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B
The modified MDS-UPDRS included 4 scales, with various subscales. Each item was rated from 0 (normal) to 4 (severe). The scales were Part I: nonmotor experiences of daily living (13 items); Part II: motor experiences of daily living (13 items); Part III: motor examination (33 scores based on 18 items \[several with right, left or other body distribution scores\]); and Part IV: motor complications (6 items). The Part II/III tremor score was calculated as the sum of 5 individual tremor item scores from Part II and Part III. The total score range for Part II/III is 0 to 44. Lower scores represent less symptom severity and higher scores represent more symptom severity. Baseline is the last measurement taken before the first dose of study drug. A negative change from baseline indicates an improvement in symptom severity. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14
Population: The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | Baseline | 19.1 score on a scale | Standard Deviation 3.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -5.4 score on a scale | Standard Deviation 4.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 1 (SAGE-217): 23 Hours Postdose | -5.9 score on a scale | Standard Deviation 5.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -6.5 score on a scale | Standard Deviation 5.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 2 (SAGE-217): 23 Hours Postdose | -6.6 score on a scale | Standard Deviation 4.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -6.0 score on a scale | Standard Deviation 4.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 3 (SAGE-217): 23 Hours Postdose | -5.9 score on a scale | Standard Deviation 5.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -8.0 score on a scale | Standard Deviation 5.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 4 (SAGE-217): 23 Hours Postdose | -7.4 score on a scale | Standard Deviation 5.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -7.4 score on a scale | Standard Deviation 7.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 5 (SAGE-217): 23 Hours Postdose | -8.0 score on a scale | Standard Deviation 5.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -5.2 score on a scale | Standard Deviation 6.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 6 (SAGE-217): 23 Hours Postdose | -8.4 score on a scale | Standard Deviation 5.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -7.7 score on a scale | Standard Deviation 4.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B | CFB at Day 14 (Follow-up) | -3.7 score on a scale | Standard Deviation 4.34 |
Primary
CFB in Urate - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part A | Baseline | 0.337 mmol/L | Standard Deviation 0.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part A | CFB at Day 4 (SAGE-217) | -0.005 mmol/L | Standard Deviation 0.0713 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part A | CFB at Day 6 (SAGE-217) | 0.010 mmol/L | Standard Deviation 0.0804 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part A | CFB at Day 8 (Follow-up) | 0.014 mmol/L | Standard Deviation 0.0394 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part A | CFB at Day 14 (Follow-up) | -0.014 mmol/L | Standard Deviation 0.0649 |
Primary
CFB in Urea Nitrogen - Part A
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part A | Baseline | 5.831 mmol/L | Standard Deviation 1.3672 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part A | CFB at Day 4 (SAGE-217) | 0.587 mmol/L | Standard Deviation 1.4925 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part A | CFB at Day 6 (SAGE-217) | 0.816 mmol/L | Standard Deviation 1.4715 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part A | CFB at Day 8 (Follow-up) | 0.663 mmol/L | Standard Deviation 1.5521 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part A | CFB at Day 14 (Follow-up) | -0.048 mmol/L | Standard Deviation 1.3484 |
Primary
Change From Baseline (CFB) in Basophils - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Change From Baseline (CFB) in Basophils - Part A | Baseline | 0.06 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.051 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Change From Baseline (CFB) in Basophils - Part A | CFB at Day 4 (SAGE-217) | -0.02 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.043 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Change From Baseline (CFB) in Basophils - Part A | CFB at Day 6 (SAGE-217) | -0.01 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.036 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Change From Baseline (CFB) in Basophils - Part A | CFB at Day 8 (Follow-up) | 0.02 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.038 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Change From Baseline (CFB) in Basophils - Part A | CFB at Day 14 (Follow-up) | -0.02 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.041 |
Primary
Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A | Suicidal Ideation: Pre-treatment | 0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A | Suicidal Ideation: Post-treatment | 0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A | Suicidal Behavior: Pre-treatment | 0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A | Suicidal Behavior: Post-treatment | 0 percentage of participants |
Primary
Percentage of Participants With TEAEs, Graded by Severity - Part A
Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with an inability to perform normal activities). The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Overall number of participants analyzed = Number of participants in the safety population that remained in the study during each period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Severe | 0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Mild | 20.0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Moderate | 6.7 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Severe | 14.3 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Mild | 0 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Moderate | 85.7 percentage of participants |
| Part A: Follow-up | Percentage of Participants With TEAEs, Graded by Severity - Part A | Severe | 0 percentage of participants |
| Part A: Follow-up | Percentage of Participants With TEAEs, Graded by Severity - Part A | Mild | 6.7 percentage of participants |
| Part A: Follow-up | Percentage of Participants With TEAEs, Graded by Severity - Part A | Moderate | 6.7 percentage of participants |
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Overall number of participants analyzed = Number of participants in the safety population that remained in the study during each period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | 26.7 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | 100 percentage of participants |
| Part A: Follow-up | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | 13.3 percentage of participants |
Secondary
CFB in Activated Partial Thromboplastin Time - Part B
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part B | Baseline | 25.05 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.40 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.05 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part B | CFB at Day 8 (Follow-up) | -0.30 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Activated Partial Thromboplastin Time - Part B | CFB at Day 14 (Follow-up) | -0.20 sec |
Secondary
CFB in Aggregate PR Interval - Part B
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | Baseline | 174.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 2.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 3 (SAGE-217): Predose | -2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 3.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 5 (SAGE-217): Predose | 1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 7 (SAGE-217): Predose | -2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate PR Interval - Part B | CFB at Day 14 (Follow-up) | -2.5 msec |
Secondary
CFB in Aggregate QRS Duration - Part B
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | Baseline | 99.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 3 (SAGE-217): Predose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 5 (SAGE-217): Predose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -3.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 7 (SAGE-217): Predose | -0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QRS Duration - Part B | CFB at Day 14 (Follow-up) | 0.5 msec |
Secondary
CFB in Aggregate QTcF Interval - Part B
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | Baseline | 407.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 3.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -2.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 3 (SAGE-217): Predose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | 0.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -1.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 5 (SAGE-217): Predose | 1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 5.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 7 (SAGE-217): Predose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QTcF Interval - Part B | CFB at Day 14 (Follow-up) | 0.5 msec |
Secondary
CFB in Aggregate QT Interval - Part B
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | Baseline | 374.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 3.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 10.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 3 (SAGE-217): Predose | 2.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | 3.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 0.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 5 (SAGE-217): Predose | -1.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -5.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 11.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 7 (SAGE-217): Predose | -5.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | 3.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 2.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate QT Interval - Part B | CFB at Day 14 (Follow-up) | 14.0 msec |
Secondary
CFB in Aggregate RR Interval - Part B
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | Baseline | 823.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | -19.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 67.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 3 (SAGE-217): Predose | -32.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -10.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 7.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 5 (SAGE-217): Predose | -23.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -24.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 50.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 7 (SAGE-217): Predose | -16.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -26.0 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 16.5 msec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aggregate RR Interval - Part B | CFB at Day 14 (Follow-up) | 66.0 msec |
Secondary
CFB in Alanine Aminotransferase - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part B | Baseline | 10.0 U/L | Standard Deviation 6.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.3 U/L | Standard Deviation 3.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part B | CFB at Dose 6 (SAGE-217): Predose | 2.6 U/L | Standard Deviation 5.42 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part B | CFB at Day 8 (Follow-up) | 1.9 U/L | Standard Deviation 3.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alanine Aminotransferase - Part B | CFB at Day 14 (Follow-up) | -0.2 U/L | Standard Deviation 3.7 |
Secondary
CFB in Albumin - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part B | Baseline | 44.2 g/L | Standard Deviation 2.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.2 g/L | Standard Deviation 1.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.6 g/L | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part B | CFB at Day 8 (Follow-up) | 0.16 g/L | Standard Deviation 1.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Albumin - Part B | CFB at Day 14 (Follow-up) | -0.1 g/L | Standard Deviation 1.86 |
Secondary
CFB in Alkaline Phosphatase - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part B | Baseline | 84.0 U/L | Standard Deviation 22.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part B | CFB at Dose 4 (SAGE-217): Predose | 1.4 U/L | Standard Deviation 7.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part B | CFB at Dose 6 (SAGE-217): Predose | 2.1 U/L | Standard Deviation 3.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part B | CFB at Day 8 (Follow-up) | 2.2 U/L | Standard Deviation 8.85 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Alkaline Phosphatase - Part B | CFB at Day 14 (Follow-up) | -1.1 U/L | Standard Deviation 8.69 |
Secondary
CFB in Aspartate Aminotransferase - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part B | Baseline | 17.7 U/L | Standard Deviation 10.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part B | CFB at Dose 4 (SAGE-217): Predose | -2.8 U/L | Standard Deviation 10.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part B | CFB at Dose 6 (SAGE-217): Predose | -1.4 U/L | Standard Deviation 10.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part B | CFB at Day 8 (Follow-up) | -0.4 U/L | Standard Deviation 11.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Aspartate Aminotransferase - Part B | CFB at Day 14 (Follow-up) | -2.4 U/L | Standard Deviation 10.12 |
Secondary
CFB in Basophils - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils - Part B | Baseline | 0.06 10^9 cells/L | Standard Deviation 0.074 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.02 10^9 cells/L | Standard Deviation 0.089 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.02 10^9 cells/L | Standard Deviation 0.058 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils - Part B | CFB at Day 8 (Follow-up) | -0.03 10^9 cells/L | Standard Deviation 0.061 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils - Part B | CFB at Day 14 (Follow-up) | 0.00 10^9 cells/L | Standard Deviation 0.055 |
Secondary
CFB in Basophils to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio (%) - Part B | Baseline | 1.0 percentage | Standard Deviation 0.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio (%) - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.2 percentage | Standard Deviation 0.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio (%) - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.1 percentage | Standard Deviation 1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio (%) - Part B | CFB at Day 8 (Follow-up) | -0.1 percentage | Standard Deviation 0.47 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Basophils to Leukocytes Ratio (%) - Part B | CFB at Day 14 (Follow-up) | 0.1 percentage | Standard Deviation 0.73 |
Secondary
CFB in Bicarbonate - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part B | Baseline | 24.6 mmol/L | Standard Deviation 1.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part B | CFB at Dose 4 (SAGE-217): Predose | -1.2 mmol/L | Standard Deviation 1.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.9 mmol/L | Standard Deviation 2.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part B | CFB at Day 8 (Follow-up) | -1.1 mmol/L | Standard Deviation 2.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bicarbonate - Part B | CFB at Day 14 (Follow-up) | -0.3 mmol/L | Standard Deviation 1.77 |
Secondary
CFB in Bilirubin - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part B | Baseline | 8.306 umol/L | Standard Deviation 2.405 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part B | CFB at Dose 4 (SAGE-217): Predose | -2.993 umol/L | Standard Deviation 2.432 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part B | CFB at Dose 6 (SAGE-217): Predose | -2.795 umol/L | Standard Deviation 2.0751 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part B | CFB at Day 8 (Follow-up) | -0.122 umol/L | Standard Deviation 2.4611 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Bilirubin - Part B | CFB at Day 14 (Follow-up) | 0.366 umol/L | Standard Deviation 3.0129 |
Secondary
CFB in Calcium - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part B | Baseline | 2.340 mmol/L | Standard Deviation 0.0796 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.006 mmol/L | Standard Deviation 0.0859 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.002 mmol/L | Standard Deviation 0.0599 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part B | CFB at Day 8 (Follow-up) | 0.023 mmol/L | Standard Deviation 0.0638 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Calcium - Part B | CFB at Day 14 (Follow-up) | -0.027 mmol/L | Standard Deviation 0.0709 |
Secondary
CFB in Chloride - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part B | Baseline | 102.1 mmol/L | Standard Deviation 2.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.1 mmol/L | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.2 mmol/L | Standard Deviation 1.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part B | CFB at Day 8 (Follow-up) | -0.5 mmol/L | Standard Deviation 2.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Chloride - Part B | CFB at Day 14 (Follow-up) | -0.2 mmol/L | Standard Deviation 2.36 |
Secondary
CFB in Creatinine - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part B | Baseline | 80.381 umol/L | Standard Deviation 23.1753 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part B | CFB at Dose 4 (SAGE-217): Predose | 11.345 umol/L | Standard Deviation 17.8035 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part B | CFB at Dose 6 (SAGE-217): Predose | 2.084 umol/L | Standard Deviation 12.3449 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part B | CFB at Day 8 (Follow-up) | -2.968 umol/L | Standard Deviation 8.0917 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Creatinine - Part B | CFB at Day 14 (Follow-up) | -0.253 umol/L | Standard Deviation 10.0339 |
Secondary
CFB in ECG Mean Heart Rate - Part B
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | Baseline | 71.4 beats/min | Standard Deviation 10.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 0.1 beats/min | Standard Deviation 5.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -6.6 beats/min | Standard Deviation 7.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 3 (SAGE-217): Predose | 0.2 beats/min | Standard Deviation 6.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -0.3 beats/min | Standard Deviation 5.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -1.6 beats/min | Standard Deviation 9.88 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 5 (SAGE-217): Predose | 2.2 beats/min | Standard Deviation 6.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 1.8 beats/min | Standard Deviation 7.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -2.4 beats/min | Standard Deviation 9.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 7 (SAGE-217): Predose | 0.2 beats/min | Standard Deviation 6.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -0.7 beats/min | Standard Deviation 6.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 1.4 beats/min | Standard Deviation 6.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in ECG Mean Heart Rate - Part B | CFB at Day 14 (Follow-up) | -6.1 beats/min | Standard Deviation 8.57 |
Secondary
CFB in Eosinophils - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part B | Baseline | 0.12 10^9 cells/L | Standard Deviation 0.058 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.05 10^9 cells/L | Standard Deviation 0.065 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.03 10^9 cells/L | Standard Deviation 0.083 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part B | CFB at Day 8 (Follow-up) | 0.03 10^9 cells/L | Standard Deviation 0.114 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils - Part B | CFB at Day 14 (Follow-up) | -0.02 10^9 cells/L | Standard Deviation 0.058 |
Secondary
CFB in Eosinophils to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part B | Baseline | 2.0 percentage | Standard Deviation 1.04 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.7 percentage | Standard Deviation 1.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.1 percentage | Standard Deviation 0.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part B | CFB at Day 8 (Follow-up) | 0.4 percentage | Standard Deviation 2.06 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Eosinophils to Leukocytes Ratio (%) - Part B | CFB at Day 14 (Follow-up) | -0.4 percentage | Standard Deviation 0.93 |
Secondary
CFB in Erythrocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part B | Baseline | 4.65 10^12 cells/L | Standard Deviation 0.335 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.16 10^12 cells/L | Standard Deviation 0.798 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.11 10^12 cells/L | Standard Deviation 0.186 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part B | CFB at Day 8 (Follow-up) | -0.02 10^12 cells/L | Standard Deviation 0.208 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Erythrocytes - Part B | CFB at Day 14 (Follow-up) | -0.06 10^12 cells/L | Standard Deviation 0.101 |
Secondary
CFB in Heart Rate - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Day 14 (Follow-up) | -5.0 beats/min | Standard Deviation 8.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | Baseline | 72.9 beats/min | Standard Deviation 9.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 0.1 beats/min | Standard Deviation 7.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | 0.1 beats/min | Standard Deviation 7.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -3.6 beats/min | Standard Deviation 15.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 2 (SAGE-217): Predose | -1.6 beats/min | Standard Deviation 7.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | 0.4 beats/min | Standard Deviation 12.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | 2.5 beats/min | Standard Deviation 11.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -3.0 beats/min | Standard Deviation 11.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 3 (SAGE-217): Predose | 0.3 beats/min | Standard Deviation 9.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -0.1 beats/min | Standard Deviation 7.67 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | 3.1 beats/min | Standard Deviation 7.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -0.1 beats/min | Standard Deviation 10.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 4 (SAGE-217): Predose | 2.5 beats/min | Standard Deviation 8.16 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | 1.4 beats/min | Standard Deviation 9.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | 1.4 beats/min | Standard Deviation 8.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -1.6 beats/min | Standard Deviation 9.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 5 (SAGE-217): Predose | 2.5 beats/min | Standard Deviation 8.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 1.9 beats/min | Standard Deviation 10.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | -0.4 beats/min | Standard Deviation 9.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -4.1 beats/min | Standard Deviation 9.12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 6 (SAGE-217): Predose | 2.1 beats/min | Standard Deviation 8.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | 1.6 beats/min | Standard Deviation 7.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | 1.2 beats/min | Standard Deviation 6.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | 2.4 beats/min | Standard Deviation 11.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 7 (SAGE-217): Predose | -1.7 beats/min | Standard Deviation 8.42 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -1.7 beats/min | Standard Deviation 8.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | 0.9 beats/min | Standard Deviation 8.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Heart Rate - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -1.3 beats/min | Standard Deviation 6.83 |
Secondary
CFB in Hematocrit - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part B | Baseline | 0.436 L/L | Standard Deviation 0.0357 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.023 L/L | Standard Deviation 0.0775 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.011 L/L | Standard Deviation 0.0182 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part B | CFB at Day 8 (Follow-up) | 0.006 L/L | Standard Deviation 0.0268 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hematocrit - Part B | CFB at Day 14 (Follow-up) | -0.002 L/L | Standard Deviation 0.0119 |
Secondary
CFB in Hemoglobin - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part B | CFB at Day 8 (Follow-up) | 1.8 g/L | Standard Deviation 6.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part B | CFB at Day 14 (Follow-up) | -0.7 g/L | Standard Deviation 4.48 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part B | Baseline | 140.1 g/L | Standard Deviation 14.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part B | CFB at Dose 4 (SAGE-217): Predose | 4.9 g/L | Standard Deviation 20.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Hemoglobin - Part B | CFB at Dose 6 (SAGE-217): Predose | -1.4 g/L | Standard Deviation 5.32 |
Secondary
CFB in Leukocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part B | Baseline | 6.47 10^9 cells/L | Standard Deviation 1.322 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.85 10^9 cells/L | Standard Deviation 2.677 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.31 10^9 cells/L | Standard Deviation 1.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part B | CFB at Day 8 (Follow-up) | -0.21 10^9 cells/L | Standard Deviation 0.935 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Leukocytes - Part B | CFB at Day 14 (Follow-up) | 0.29 10^9 cells/L | Standard Deviation 1.287 |
Secondary
CFB in Lipase - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part B | Baseline | 37.2 U/L | Standard Deviation 16.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part B | CFB at Dose 4 (SAGE-217): Predose | 15.4 U/L | Standard Deviation 9.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part B | CFB at Dose 6 (SAGE-217): Predose | 19.4 U/L | Standard Deviation 16.88 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part B | CFB at Day 8 (Follow-up) | 4.3 U/L | Standard Deviation 6.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lipase - Part B | CFB at Day 14 (Follow-up) | 1.6 U/L | Standard Deviation 9.3 |
Secondary
CFB in Lymphocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part B | Baseline | 1.68 10^9 cells/L | Standard Deviation 0.549 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.44 10^9 cells/L | Standard Deviation 0.857 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.26 10^9 cells/L | Standard Deviation 0.386 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part B | CFB at Day 8 (Follow-up) | 0.18 10^9 cells/L | Standard Deviation 0.283 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes - Part B | CFB at Day 14 (Follow-up) | 0.11 10^9 cells/L | Standard Deviation 0.373 |
Secondary
CFB in Lymphocytes to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part B | Baseline | 26.0 percentage | Standard Deviation 6.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part B | CFB at Dose 4 (SAGE-217): Predose | 2.5 percentage | Standard Deviation 6.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part B | CFB at Dose 6 (SAGE-217): Predose | 2.6 percentage | Standard Deviation 5.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part B | CFB at Day 8 (Follow-up) | 3.4 percentage | Standard Deviation 5.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Lymphocytes to Leukocytes Ratio (%) - Part B | CFB at Day 14 (Follow-up) | 0.6 percentage | Standard Deviation 5.73 |
Secondary
CFB in Magnesium - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part B | Baseline | 0.873 mmol/L | Standard Deviation 0.0489 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.014 mmol/L | Standard Deviation 0.0536 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.009 mmol/L | Standard Deviation 0.0401 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part B | CFB at Day 8 (Follow-up) | 0.018 mmol/L | Standard Deviation 0.0448 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Magnesium - Part B | CFB at Day 14 (Follow-up) | -0.012 mmol/L | Standard Deviation 0.0591 |
Secondary
CFB in Monocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part B | Baseline | 0.40 10^9 cells/L | Standard Deviation 0.096 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.09 10^9 cells/L | Standard Deviation 0.194 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.03 10^9 cells/L | Standard Deviation 0.083 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part B | CFB at Day 8 (Follow-up) | 0.03 10^9 cells/L | Standard Deviation 0.133 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes - Part B | CFB at Day 14 (Follow-up) | 0.01 10^9 cells/L | Standard Deviation 0.11 |
Secondary
CFB in Monocytes to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part B | Baseline | 6.4 percentage | Standard Deviation 1.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.3 percentage | Standard Deviation 1.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.1 percentage | Standard Deviation 1.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part B | CFB at Day 8 (Follow-up) | 0.4 percentage | Standard Deviation 1.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Monocytes to Leukocytes Ratio (%) - Part B | CFB at Day 14 (Follow-up) | -0.1 percentage | Standard Deviation 1.07 |
Secondary
CFB in Neutrophils - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils - Part B | Baseline | 4.23 10^9 cells/L | Standard Deviation 0.957 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.23 10^9 cells/L | Standard Deviation 1.842 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.00 10^9 cells/L | Standard Deviation 1.136 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils - Part B | CFB at Day 8 (Follow-up) | -0.43 10^9 cells/L | Standard Deviation 0.902 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils - Part B | CFB at Day 14 (Follow-up) | 0.16 10^9 cells/L | Standard Deviation 1.153 |
Secondary
CFB in Neutrophils to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part B | Baseline | 65.3 percentage | Standard Deviation 5.28 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part B | CFB at Dose 4 (SAGE-217): Predose | -4.2 percentage | Standard Deviation 7.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part B | CFB at Dose 6 (SAGE-217): Predose | -3.0 percentage | Standard Deviation 6.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part B | CFB at Day 8 (Follow-up) | -4.4 percentage | Standard Deviation 6.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Neutrophils to Leukocytes Ratio (%) - Part B | CFB at Day 14 (Follow-up) | -0.4 percentage | Standard Deviation 6.69 |
Secondary
CFB in Phosphate - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part B | Baseline | 1.091 mmol/L | Standard Deviation 0.1489 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.161 mmol/L | Standard Deviation 0.1496 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.180 mmol/L | Standard Deviation 0.1386 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part B | CFB at Day 8 (Follow-up) | 0.042 mmol/L | Standard Deviation 0.1775 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Phosphate - Part B | CFB at Day 14 (Follow-up) | 0.009 mmol/L | Standard Deviation 0.1939 |
Secondary
CFB in pH - Part B
Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part B | Baseline | 6.11 pH | Standard Deviation 0.924 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.18 pH | Standard Deviation 1.103 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.32 pH | Standard Deviation 1.085 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part B | CFB at Day 8 (Follow-up) | 0.39 pH | Standard Deviation 0.984 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in pH - Part B | CFB at Day 14 (Follow-up) | -0.12 pH | Standard Deviation 0.82 |
Secondary
CFB in Platelets - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part B | Baseline | 189.2 10^9 cells/L | Standard Deviation 37.72 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part B | CFB at Dose 4 (SAGE-217): Predose | 24.1 10^9 cells/L | Standard Deviation 67.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part B | CFB at Dose 6 (SAGE-217): Predose | 5.9 10^9 cells/L | Standard Deviation 13.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part B | CFB at Day 8 (Follow-up) | 0.8 10^9 cells/L | Standard Deviation 20.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Platelets - Part B | CFB at Day 14 (Follow-up) | 5.3 10^9 cells/L | Standard Deviation 19.58 |
Secondary
CFB in Potassium - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part B | Baseline | 4.57 mmol/L | Standard Deviation 0.292 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.03 mmol/L | Standard Deviation 0.319 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.11 mmol/L | Standard Deviation 0.264 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part B | CFB at Day 8 (Follow-up) | -0.11 mmol/L | Standard Deviation 0.295 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Potassium - Part B | CFB at Day 14 (Follow-up) | -0.01 mmol/L | Standard Deviation 0.268 |
Secondary
CFB in Protein - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part B | Baseline | 69.6 g/L | Standard Deviation 5.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.8 g/L | Standard Deviation 1.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.9 g/L | Standard Deviation 3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part B | CFB at Day 8 (Follow-up) | 0.9 g/L | Standard Deviation 2.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Protein - Part B | CFB at Day 14 (Follow-up) | -0.1 g/L | Standard Deviation 3 |
Secondary
CFB in Prothrombin International Normalized Ratio - Part B
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part B | Baseline | 0.98 ratio | Standard Deviation 0.043 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.03 ratio | Standard Deviation 0.045 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.01 ratio | Standard Deviation 0.051 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part B | CFB at Day 8 (Follow-up) | 0.00 ratio | Standard Deviation 0.041 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin International Normalized Ratio - Part B | CFB at Day 14 (Follow-up) | 0.01 ratio | Standard Deviation 0.036 |
Secondary
CFB in Prothrombin Time - Part B
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part B | Baseline | 10.60 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.20 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.05 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part B | CFB at Day 8 (Follow-up) | -0.10 sec |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Prothrombin Time - Part B | CFB at Day 14 (Follow-up) | 0.10 sec |
Secondary
CFB in Pulse Oximetry - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | Baseline | 96.9 percentage | Standard Deviation 1.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | -0.6 percentage | Standard Deviation 1.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | 0.0 percentage | Standard Deviation 2.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 0.4 percentage | Standard Deviation 1.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 2 (SAGE-217): Predose | -0.3 percentage | Standard Deviation 1.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | 0.1 percentage | Standard Deviation 1.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | 0.1 percentage | Standard Deviation 1.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | 0.3 percentage | Standard Deviation 1.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 3 (SAGE-217): Predose | 0.1 percentage | Standard Deviation 1.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | 0.3 percentage | Standard Deviation 2.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -0.5 percentage | Standard Deviation 1.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 0.0 percentage | Standard Deviation 2.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.6 percentage | Standard Deviation 1.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | 0.6 percentage | Standard Deviation 1.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | 0.1 percentage | Standard Deviation 1.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -0.3 percentage | Standard Deviation 2.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 5 (SAGE-217): Predose | 0.5 percentage | Standard Deviation 1.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 0.6 percentage | Standard Deviation 1.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | 0.0 percentage | Standard Deviation 1.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 0.4 percentage | Standard Deviation 1.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 6 (SAGE-217): Predose | -0.2 percentage | Standard Deviation 1.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | 0.1 percentage | Standard Deviation 1.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | 0.1 percentage | Standard Deviation 1.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | 0.3 percentage | Standard Deviation 1.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 7 (SAGE-217): Predose | 0.2 percentage | Standard Deviation 1.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -0.4 percentage | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | 0.0 percentage | Standard Deviation 1.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 0.1 percentage | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Pulse Oximetry - Part B | CFB at Day 14 (Follow-up) | 0.5 percentage | Standard Deviation 1.91 |
Secondary
CFB in Respiratory Rate - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | Baseline | 15.6 breaths/min | Standard Deviation 1.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 0.6 breaths/min | Standard Deviation 1.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | 0.6 breaths/min | Standard Deviation 1.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 0.8 breaths/min | Standard Deviation 1.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 2 (SAGE-217): Predose | -0.9 breaths/min | Standard Deviation 2.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | -0.9 breaths/min | Standard Deviation 2.09 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | 0.4 breaths/min | Standard Deviation 1.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | 0.8 breaths/min | Standard Deviation 1.58 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 3 (SAGE-217): Predose | 0.5 breaths/min | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -0.4 breaths/min | Standard Deviation 1.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -0.6 breaths/min | Standard Deviation 2.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 0.6 breaths/min | Standard Deviation 1.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.2 breaths/min | Standard Deviation 2.36 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | -0.4 breaths/min | Standard Deviation 1.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | -0.3 breaths/min | Standard Deviation 1.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | 1.4 breaths/min | Standard Deviation 1.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 5 (SAGE-217): Predose | 0.4 breaths/min | Standard Deviation 1.45 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | 1.4 breaths/min | Standard Deviation 1.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | 0.6 breaths/min | Standard Deviation 2.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 0.4 breaths/min | Standard Deviation 1.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.4 breaths/min | Standard Deviation 1.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | -0.1 breaths/min | Standard Deviation 1.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | 0.5 breaths/min | Standard Deviation 1.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | 0.4 breaths/min | Standard Deviation 1.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 7 (SAGE-217): Predose | -1.1 breaths/min | Standard Deviation 2.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | 1.6 breaths/min | Standard Deviation 1.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | -0.7 breaths/min | Standard Deviation 2.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 0.6 breaths/min | Standard Deviation 1.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Respiratory Rate - Part B | CFB at Day 14 (Follow-up) | 0.3 breaths/min | Standard Deviation 1.9 |
Secondary
CFB in Reticulocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part B | Baseline | 59.3 10^9 cells/L | Standard Deviation 19.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part B | CFB at Dose 4 (SAGE-217): Predose | 1.1 10^9 cells/L | Standard Deviation 11.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part B | CFB at Dose 6 (SAGE-217): Predose | 5.1 10^9 cells/L | Standard Deviation 19.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part B | CFB at Day 8 (Follow-up) | 2.4 10^9 cells/L | Standard Deviation 15.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes - Part B | CFB at Day 14 (Follow-up) | 5.1 10^9 cells/L | Standard Deviation 20.99 |
Secondary
CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B | Baseline | 1.28 percentage | Standard Deviation 0.417 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.04 percentage | Standard Deviation 0.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.13 percentage | Standard Deviation 0.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B | CFB at Day 8 (Follow-up) | 0.05 percentage | Standard Deviation 0.334 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B | CFB at Day 14 (Follow-up) | 0.13 percentage | Standard Deviation 0.486 |
Secondary
CFB in Sodium - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part B | Baseline | 141.8 mmol/L | Standard Deviation 1.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.1 mmol/L | Standard Deviation 1.78 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.1 mmol/L | Standard Deviation 1.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part B | CFB at Day 8 (Follow-up) | 0.4 mmol/L | Standard Deviation 2.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Sodium - Part B | CFB at Day 14 (Follow-up) | -0.1 mmol/L | Standard Deviation 3 |
Secondary
CFB in Specific Gravity - Part B
Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part B | Baseline | 1.018 ratio | Standard Deviation 0.0061 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part B | CFB at Dose 4 (SAGE-217): Predose | 0.003 ratio | Standard Deviation 0.0038 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.001 ratio | Standard Deviation 0.0053 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part B | CFB at Day 8 (Follow-up) | -0.004 ratio | Standard Deviation 0.0077 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Specific Gravity - Part B | CFB at Day 14 (Follow-up) | 0.000 ratio | Standard Deviation 0.0063 |
Secondary
CFB in Standing Diastolic Blood Pressure - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | Baseline | 81.9 mmHg | Standard Deviation 6.99 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | -2.0 mmHg | Standard Deviation 6.04 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | -2.4 mmHg | Standard Deviation 6.32 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -1.6 mmHg | Standard Deviation 7.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): Predose | -3.9 mmHg | Standard Deviation 7.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | -2.4 mmHg | Standard Deviation 5.11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | -1.5 mmHg | Standard Deviation 7.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -1.9 mmHg | Standard Deviation 8.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): Predose | -3.9 mmHg | Standard Deviation 8.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -1.4 mmHg | Standard Deviation 9.08 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -1.1 mmHg | Standard Deviation 7.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -2.4 mmHg | Standard Deviation 7.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): Predose | -2.4 mmHg | Standard Deviation 7.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | -4.1 mmHg | Standard Deviation 9.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | -2.9 mmHg | Standard Deviation 8.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -2.8 mmHg | Standard Deviation 9.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): Predose | -5.5 mmHg | Standard Deviation 8.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -1.4 mmHg | Standard Deviation 7.91 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | -3.1 mmHg | Standard Deviation 8.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 0.0 mmHg | Standard Deviation 10.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): Predose | -4.0 mmHg | Standard Deviation 7.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | -1.6 mmHg | Standard Deviation 8.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | -2.0 mmHg | Standard Deviation 7.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -2.1 mmHg | Standard Deviation 8.27 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): Predose | -1.7 mmHg | Standard Deviation 9.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -0.2 mmHg | Standard Deviation 8.86 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | 0.6 mmHg | Standard Deviation 8.14 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -2.7 mmHg | Standard Deviation 8.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Diastolic Blood Pressure - Part B | CFB at Day 14 (Follow-up) | -1.1 mmHg | Standard Deviation 9.21 |
Secondary
CFB in Standing Systolic Blood Pressure - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | Baseline | 127.8 mmHg | Standard Deviation 14.89 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | -2.9 mmHg | Standard Deviation 10.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | -2.4 mmHg | Standard Deviation 8.41 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 0.6 mmHg | Standard Deviation 7.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): Predose | -3.4 mmHg | Standard Deviation 15.96 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | -1.5 mmHg | Standard Deviation 14.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | 1.7 mmHg | Standard Deviation 15.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -0.8 mmHg | Standard Deviation 13.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): Predose | -4.2 mmHg | Standard Deviation 11.77 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -0.8 mmHg | Standard Deviation 11.56 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -4.4 mmHg | Standard Deviation 11.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 0.0 mmHg | Standard Deviation 17.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): Predose | -4.5 mmHg | Standard Deviation 12.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | -4.1 mmHg | Standard Deviation 18.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | -5.5 mmHg | Standard Deviation 11.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -3.8 mmHg | Standard Deviation 13.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): Predose | -7.5 mmHg | Standard Deviation 8.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -3.9 mmHg | Standard Deviation 12.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | -5.6 mmHg | Standard Deviation 14.59 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -2.3 mmHg | Standard Deviation 10.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): Predose | -9.4 mmHg | Standard Deviation 8.8 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | -6.6 mmHg | Standard Deviation 11.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | -4.7 mmHg | Standard Deviation 10.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -8.6 mmHg | Standard Deviation 11.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): Predose | -1.2 mmHg | Standard Deviation 9.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | 1.4 mmHg | Standard Deviation 10.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | 3.5 mmHg | Standard Deviation 13.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -7.5 mmHg | Standard Deviation 12.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Standing Systolic Blood Pressure - Part B | CFB at Day 14 (Follow-up) | 0.7 mmHg | Standard Deviation 14.5 |
Secondary
CFB in Supine Diastolic Blood Pressure - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | Baseline | 78.2 mmHg | Standard Deviation 7.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | 0.7 mmHg | Standard Deviation 7.13 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | 1.6 mmHg | Standard Deviation 7.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 0.6 mmHg | Standard Deviation 7.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): Predose | -0.1 mmHg | Standard Deviation 10 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | 1.9 mmHg | Standard Deviation 9.23 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | -0.5 mmHg | Standard Deviation 9.75 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | 1.9 mmHg | Standard Deviation 9.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): Predose | 0.1 mmHg | Standard Deviation 8.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -1.4 mmHg | Standard Deviation 7.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -0.9 mmHg | Standard Deviation 12.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | 0.6 mmHg | Standard Deviation 11.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.3 mmHg | Standard Deviation 9.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | 1.5 mmHg | Standard Deviation 8.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | 0.3 mmHg | Standard Deviation 8.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | 0.4 mmHg | Standard Deviation 9.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): Predose | -1.1 mmHg | Standard Deviation 9.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -0.7 mmHg | Standard Deviation 9.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | -0.6 mmHg | Standard Deviation 9.44 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -0.6 mmHg | Standard Deviation 9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): Predose | -2.4 mmHg | Standard Deviation 9.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | 1.1 mmHg | Standard Deviation 9.49 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | 0.6 mmHg | Standard Deviation 9.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | 1.9 mmHg | Standard Deviation 9.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): Predose | -0.6 mmHg | Standard Deviation 9.16 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | 1.8 mmHg | Standard Deviation 10.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | 0.2 mmHg | Standard Deviation 8.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | 0.4 mmHg | Standard Deviation 8.93 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Diastolic Blood Pressure - Part B | CFB at Day 14 (Follow-up) | 0.3 mmHg | Standard Deviation 8.3 |
Secondary
CFB in Supine Systolic Blood Pressure - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | Baseline | 131.7 mmHg | Standard Deviation 16.5 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | -1.7 mmHg | Standard Deviation 9.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | -1.4 mmHg | Standard Deviation 7.6 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | 0.3 mmHg | Standard Deviation 13.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): Predose | -3.3 mmHg | Standard Deviation 18.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | 2.9 mmHg | Standard Deviation 14.61 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | 0.1 mmHg | Standard Deviation 16.11 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | 6.1 mmHg | Standard Deviation 18.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): Predose | -1.2 mmHg | Standard Deviation 12.35 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -0.1 mmHg | Standard Deviation 10.64 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -1.6 mmHg | Standard Deviation 13.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -1.1 mmHg | Standard Deviation 22.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): Predose | -1.4 mmHg | Standard Deviation 16.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | -1.1 mmHg | Standard Deviation 14.22 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | -4.3 mmHg | Standard Deviation 14.21 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | 1.2 mmHg | Standard Deviation 18.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): Predose | -5.7 mmHg | Standard Deviation 14.67 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -4.0 mmHg | Standard Deviation 15.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | -3.6 mmHg | Standard Deviation 18.79 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | 2.3 mmHg | Standard Deviation 11.82 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): Predose | -10.9 mmHg | Standard Deviation 17.18 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | -6.5 mmHg | Standard Deviation 18.68 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | -2.8 mmHg | Standard Deviation 18.48 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -4.1 mmHg | Standard Deviation 15.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): Predose | -1.7 mmHg | Standard Deviation 12.63 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | 2.4 mmHg | Standard Deviation 12.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | 2.5 mmHg | Standard Deviation 11.94 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -1.2 mmHg | Standard Deviation 13.98 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Supine Systolic Blood Pressure - Part B | CFB at Day 14 (Follow-up) | 3.4 mmHg | Standard Deviation 15.55 |
Secondary
CFB in Temperature - Part B
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | Baseline | 36.56 degrees C | Standard Deviation 0.306 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 1 (SAGE-217): 1 Hour Postdose | -0.10 degrees C | Standard Deviation 0.199 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 1 (SAGE-217): 2 Hours Postdose | 0.01 degrees C | Standard Deviation 0.316 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -0.19 degrees C | Standard Deviation 0.316 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 2 (SAGE-217): Predose | -0.23 degrees C | Standard Deviation 0.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 2 (SAGE-217): 1 Hour Postdose | -0.15 degrees C | Standard Deviation 0.375 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 2 (SAGE-217): 2 Hours Postdose | -0.03 degrees C | Standard Deviation 0.31 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -0.09 degrees C | Standard Deviation 0.38 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 3 (SAGE-217): Predose | -0.06 degrees C | Standard Deviation 0.485 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 3 (SAGE-217): 1 Hour Postdose | -0.11 degrees C | Standard Deviation 0.327 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 3 (SAGE-217): 2 Hours Postdose | -0.15 degrees C | Standard Deviation 0.282 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -0.06 degrees C | Standard Deviation 0.386 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.10 degrees C | Standard Deviation 0.451 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 4 (SAGE-217): 1 Hour Postdose | 0.01 degrees C | Standard Deviation 0.408 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 4 (SAGE-217): 2 Hours Postdose | -0.09 degrees C | Standard Deviation 0.358 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -0.12 degrees C | Standard Deviation 0.336 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 5 (SAGE-217): Predose | -0.08 degrees C | Standard Deviation 0.418 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 5 (SAGE-217): 1 Hour Postdose | -0.08 degrees C | Standard Deviation 0.423 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 5 (SAGE-217): 2 Hours Postdose | -0.09 degrees C | Standard Deviation 0.562 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -0.09 degrees C | Standard Deviation 0.512 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.01 degrees C | Standard Deviation 0.24 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 6 (SAGE-217): 1 Hour Postdose | 0.05 degrees C | Standard Deviation 0.266 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 6 (SAGE-217): 2 Hours Postdose | -0.05 degrees C | Standard Deviation 0.289 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -0.07 degrees C | Standard Deviation 0.363 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 7 (SAGE-217): Predose | -0.07 degrees C | Standard Deviation 0.477 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 7 (SAGE-217): 1 Hour Postdose | -0.10 degrees C | Standard Deviation 0.348 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 7 (SAGE-217): 2 Hours Postdose | -0.08 degrees C | Standard Deviation 0.352 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -0.10 degrees C | Standard Deviation 0.415 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Temperature - Part B | CFB at Day 14 (Follow-up) | -0.01 degrees C | Standard Deviation 0.291 |
Secondary
CFB in the MDS-UPDRS Part III Total Score - Part B
Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of the individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores represent less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14
Population: The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | Baseline | 52.4 score on a scale | Standard Deviation 12 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -8.4 score on a scale | Standard Deviation 8.74 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 1 (SAGE-217): 23 Hours Postdose | -10.8 score on a scale | Standard Deviation 9.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -11.6 score on a scale | Standard Deviation 12.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 2 (SAGE-217): 23 Hours Postdose | -13.5 score on a scale | Standard Deviation 7.87 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -12.4 score on a scale | Standard Deviation 10.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 3 (SAGE-217): 23 Hours Postdose | -10.9 score on a scale | Standard Deviation 9.39 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -14.3 score on a scale | Standard Deviation 12.25 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 4 (SAGE-217): 23 Hours Postdose | -14.8 score on a scale | Standard Deviation 10.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -14.5 score on a scale | Standard Deviation 15.52 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 5 (SAGE-217): 23 Hours Postdose | -18.1 score on a scale | Standard Deviation 10.1 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -14.8 score on a scale | Standard Deviation 11.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 6 (SAGE-217): 23 Hours Postdose | -19.5 score on a scale | Standard Deviation 9.3 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -18.6 score on a scale | Standard Deviation 9.51 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part III Total Score - Part B | CFB at Day 14 (Follow-up) | -14.5 score on a scale | Standard Deviation 10.54 |
Secondary
CFB in the MDS-UPDRS Part II Total Score - Part B
Part II of the MDS-UPDRS assessed 13 categories of motor experiences of daily living: speech, salivation and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, car, or deep chair, walking and balance, and freezing. The Part II total score was calculated as the sum of the individual item scores from these categories. The total score range for Part II is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14
Population: The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | Baseline | 15.1 score on a scale | Standard Deviation 8.26 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 1 (SAGE-217): 12 Hours Postdose | -1.9 score on a scale | Standard Deviation 3.46 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 1 (SAGE-217): 23 Hours Postdose | -1.7 score on a scale | Standard Deviation 3.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 2 (SAGE-217): 12 Hours Postdose | -2.1 score on a scale | Standard Deviation 5.17 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 2 (SAGE-217): 23 Hours Postdose | -2.2 score on a scale | Standard Deviation 4.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 3 (SAGE-217): 12 Hours Postdose | -2.0 score on a scale | Standard Deviation 5.48 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 3 (SAGE-217): 23 Hours Postdose | -3.1 score on a scale | Standard Deviation 4.2 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 4 (SAGE-217): 12 Hours Postdose | -3.4 score on a scale | Standard Deviation 6.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 4 (SAGE-217): 23 Hours Postdose | -2.4 score on a scale | Standard Deviation 5.43 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 5 (SAGE-217): 12 Hours Postdose | -4.6 score on a scale | Standard Deviation 5.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 5 (SAGE-217): 23 Hours Postdose | -2.9 score on a scale | Standard Deviation 4.9 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 6 (SAGE-217): 12 Hours Postdose | -2.9 score on a scale | Standard Deviation 5.05 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 6 (SAGE-217): 23 Hours Postdose | -3.9 score on a scale | Standard Deviation 5.4 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -3.9 score on a scale | Standard Deviation 4.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part II Total Score - Part B | CFB at Day 14 (Follow-up) | -3.9 score on a scale | Standard Deviation 5.02 |
Secondary
CFB in the MDS-UPDRS Part I-IV Total Score - Part B
The MDS-UPDRS assesses nonmotor experiences, motor experiences, motor skills, and motor complication categories. The MDS-UPDRS Part I-IV total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I-IV is 0 to 260. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Day 7 (12 hours postdose), Day 14
Population: The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part I-IV Total Score - Part B | Baseline | 84.6 score on a scale | Standard Deviation 24.01 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part I-IV Total Score - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -30.0 score on a scale | Standard Deviation 17.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part I-IV Total Score - Part B | CFB at Day 14 (Follow-up) | -24.1 score on a scale | Standard Deviation 20.75 |
Secondary
CFB in the MDS-UPDRS Part I Total Score - Part B
Part I of the MDS-UPDRS assessed 13 nonmotor experiences of daily living categories. Part I total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Day 7 (12 hours postdose), Day 14
Population: The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part I Total Score - Part B | Baseline | 9.9 score on a scale | Standard Deviation 6.33 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part I Total Score - Part B | CFB at Dose 7 (SAGE-217): 12 Hours Postdose | -4.7 score on a scale | Standard Deviation 6.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in the MDS-UPDRS Part I Total Score - Part B | CFB at Day 14 (Follow-up) | -3.9 score on a scale | Standard Deviation 6.05 |
Secondary
CFB in Urate - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part B | Baseline | 0.291 mmol/L | Standard Deviation 0.0748 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part B | CFB at Dose 4 (SAGE-217): Predose | -0.001 mmol/L | Standard Deviation 0.0252 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part B | CFB at Dose 6 (SAGE-217): Predose | 0.001 mmol/L | Standard Deviation 0.036 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part B | CFB at Day 8 (Follow-up) | 0.006 mmol/L | Standard Deviation 0.0254 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urate - Part B | CFB at Day 14 (Follow-up) | 0.007 mmol/L | Standard Deviation 0.0319 |
Secondary
CFB in Urea Nitrogen - Part B
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part B | Baseline | 5.993 mmol/L | Standard Deviation 1.7667 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part B | CFB at Dose 4 (SAGE-217): Predose | 2.142 mmol/L | Standard Deviation 1.9554 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part B | CFB at Dose 6 (SAGE-217): Predose | 1.275 mmol/L | Standard Deviation 1.7917 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part B | CFB at Day 8 (Follow-up) | 0.663 mmol/L | Standard Deviation 1.9345 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | CFB in Urea Nitrogen - Part B | CFB at Day 14 (Follow-up) | 0.153 mmol/L | Standard Deviation 1.258 |
Secondary
MDS-UPDRS Part III Total Score - Part A
Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores indicate less symptom severity. The analysis was performed in participants included in Part A of the study.
Time frame: Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14
Population: The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 1 (L/C): 2 Hours Postdose | 25.4 score on a scale | Standard Deviation 9.34 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 1 (L/C): 4 Hours Postdose | 30.0 score on a scale | Standard Deviation 10.53 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 1 (L/C): 8 Hours Postdose | 34.3 score on a scale | Standard Deviation 10.83 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 1 (L/C): 12 Hours Postdose | 35.1 score on a scale | Standard Deviation 9.71 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 2 (L/C): 2 Hours Postdose | 27.1 score on a scale | Standard Deviation 9.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 2 (L/C): 4 Hours Postdose | 31.1 score on a scale | Standard Deviation 9.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 2 (L/C): 8 Hours Postdose | 35.1 score on a scale | Standard Deviation 11.37 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 2 (L/C): 12 Hours Postdose | 36.1 score on a scale | Standard Deviation 11.07 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 3 (L/C): 2 Hours Postdose | 26.5 score on a scale | Standard Deviation 10.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 3 (L/C): 4 Hours Postdose | 29.0 score on a scale | Standard Deviation 10.95 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 3 (L/C): 8 Hours Postdose | 35.2 score on a scale | Standard Deviation 10.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 3 (L/C): 12 Hours Postdose | 36.2 score on a scale | Standard Deviation 11.29 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 4 (SAGE-217): 2 Hours Postdose | 35.7 score on a scale | Standard Deviation 14.57 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 4 (SAGE-217): 4 Hours Postdose | 30.9 score on a scale | Standard Deviation 12.84 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 4 (SAGE-217):8 Hours Postdose | 33.4 score on a scale | Standard Deviation 11.65 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 4 (SAGE-217): 12 Hours Postdose | 33.3 score on a scale | Standard Deviation 13.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 5 (SAGE-217): 2 Hours Postdose | 33.8 score on a scale | Standard Deviation 12.76 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 5 (SAGE-217): 4 Hours Postdose | 32.4 score on a scale | Standard Deviation 12.69 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 5 (SAGE-217): 8 Hours Postdose | 30.9 score on a scale | Standard Deviation 12.02 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 5 (SAGE-217): 12 Hours Postdose | 33.0 score on a scale | Standard Deviation 12.15 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 6 (SAGE-217): 2 Hours Postdose | 31.5 score on a scale | Standard Deviation 11.97 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 6 (SAGE-217): 4 Hours Postdose | 31.8 score on a scale | Standard Deviation 9.66 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 6 (SAGE-217): 8 Hours Postdose | 32.7 score on a scale | Standard Deviation 12.81 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 6 (SAGE-217): 12 Hours Postdose | 34.5 score on a scale | Standard Deviation 11.19 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 7 (SAGE-217): 2 Hours Postdose | 36.4 score on a scale | Standard Deviation 12.55 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 7 (SAGE-217): 4 Hours Postdose | 35.8 score on a scale | Standard Deviation 11.92 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 7 (SAGE-217): 8 Hours Postdose | 36.0 score on a scale | Standard Deviation 11.73 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 7 (SAGE-217): 12 Hours Postdose | 35.6 score on a scale | Standard Deviation 11.03 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 8 (Follow-up) | 35.4 score on a scale | Standard Deviation 10.54 |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | MDS-UPDRS Part III Total Score - Part A | Day 14 (Follow-up) | 30.2 score on a scale | Standard Deviation 13 |
Secondary
Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B | Suicidal Ideation: Wish to be Dead: Pre-treatment | 14.3 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B | Suicidal Ideation: Wish to be Dead: Post-treatment | 0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B | Suicidal Behavior: Pre-treatment | 0 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B | Suicidal Behavior: Post-treatment | 0 percentage of participants |
Secondary
Percentage of Participants With TEAEs, Graded by Severity - Part B
Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Mild | 42.9 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Moderate | 14.3 percentage of participants |
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Severe | 0 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Mild | 0 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Moderate | 0 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Severe | 0 percentage of participants |
Secondary
Percentage of Participants With TEAEs - Part B
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 to Day 14
Population: The safety population included all participants who were administered study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Percentage of Participants With TEAEs - Part B | 57.1 percentage of participants |
| Part A: SAGE-217 Day 4 to Day 7 | Percentage of Participants With TEAEs - Part B | 0 percentage of participants |