A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease

NCT03000569 | Completed Phase 2 Results

• 1 other identifier: 217-PRK-201
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 11

Brief Summary

This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.

Conditions

Parkinson Disease

Keywords

Parkinson's

Outcome Measures

Primary Outcomes (58)

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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 (%).

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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 (%).

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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 (%).

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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 (%).

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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 (%).

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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 (%).

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Day 1 to Day 14

• 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.

  Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14

Secondary Outcomes (61)

• MDS-UPDRS Part III Total Score - Part A

  Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14

• 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

• CFB in the MDS-UPDRS Part I Total Score - Part B

  Baseline, Day 7 (12 hours postdose), Day 14

• 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

• CFB in the MDS-UPDRS Part I-IV Total Score - Part B

  Baseline, Day 7 (12 hours postdose), Day 14

Study Arms (2)

Part A: Antiparkinsonian Agent(s) Followed by SAGE-217

EXPERIMENTAL

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.

Drug: SAGE-217; Drug: Levodopa

Part B: Antiparkinsonian Agent(s) + SAGE-217

EXPERIMENTAL

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.

Drug: SAGE-217; Drug: Antiparkinsonian Agent(s)

Interventions

SAGE-217 DRUG

Part A: Antiparkinsonian Agent(s) Followed by SAGE-217; Part B: Antiparkinsonian Agent(s) + SAGE-217

Levodopa DRUG

Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).

Part A: Antiparkinsonian Agent(s) Followed by SAGE-217

Antiparkinsonian Agent(s) DRUG

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.

Part B: Antiparkinsonian Agent(s) + SAGE-217

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (11)

Sage Investigational Site

Panorama City, California, 91402, United States

Location

Sage Investigational Site

Jacksonville, Florida, 32216, United States

Location

Sage Investigational Site

Miami, Florida, 33135, United States

Location

Sage Investigational Site

Miami, Florida, 33143, United States

Location

Sage Investigational Site

Orlando, Florida, 32806, United States

Location

Sage Investigational Site

Winter Park, Florida, 32789, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Sage Investigational Site

Berlin, New Jersey, 08009, United States

Location

Sage Investigational Site

Houston, Texas, 77058, United States

Location

Sage Investigational Site

Orem, Utah, 84058, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Interventions

zuranolone; Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 22, 2016
• Study Start: November 30, 2016
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2017
• Last Updated: November 29, 2023
• Results First Posted: November 23, 2020

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (11)