Phase 2
Completed N=29
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Source: ClinicalTrials.gov NCT03000569 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A — 26.7; 100; 13.3 percentage of participants
Summary
This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A |
26.7; 100; 13.3 | — |
| PRIMARY Percentage of Participants With TEAEs, Graded by Severity - Part A |
20.0; 0; 6.7; 6.7; 85.7; 6.7 | — |
| PRIMARY Change From Baseline (CFB) in Basophils - Part A |
0.06; -0.02; -0.01; 0.02; -0.02 | — |
| PRIMARY CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A |
0.8; 0.1; 0.3; 0.0; 0.1 | — |
| PRIMARY CFB in Eosinophils - Part A |
0.17; 0.07; 0.04; 0.02; 0.00 | — |
| PRIMARY CFB in Eosinophils to Leukocytes Ratio (%) - Part A |
2.9; 0.7; 0.3; 0.0; -0.3 | — |
| PRIMARY CFB in Erythrocytes - Part A |
4.63; 0.01; 0.04; 0.02; -0.09 | — |
| PRIMARY CFB in Hematocrit - Part A |
0.434; 0.003; 0.004; -0.002; -0.013 | — |
| PRIMARY CFB in Hemoglobin - Part A |
142.0; 0.1; 1.7; 1.2; -1.9 | — |
| PRIMARY CFB in Leukocytes - Part A |
6.04; -0.24; 0.15; -0.09; 0.30 | — |
| PRIMARY CFB in Lymphocytes - Part A |
1.70; -0.02; 0.07; 0.02; -0.17 | — |
| PRIMARY CFB in Lymphocytes to Leukocytes Ratio (%) - Part A |
28.3; 1.0; 1.0; 0.9; -3.9 | — |
| PRIMARY CFB in Monocytes - Part A |
0.36; 0.02; 0.06; 0.02; 0.05 | — |
| PRIMARY CFB in Monocytes to Leukocytes Ratio (%) - Part A |
6.1; 0.2; 0.6; 0.5; 0.3 | — |
| PRIMARY CFB in Neutrophils- Part A |
3.79; -0.27; -0.03; -0.17; 0.44 | — |
| PRIMARY CFB in Neutrophils to Leukocytes Ratio (%) - Part A |
62.5; -2.4; -2.4; -2.2; 3.6 | — |
| PRIMARY CFB in Platelets - Part A |
218.9; 6.6; 6.8; 7.8; 11.5 | — |
| PRIMARY CFB in Reticulocytes - Part A |
64.6; -0.3; 0.3; 0.2; 0.3 | — |
| PRIMARY CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A |
1.41; 0.00; -0.03; 0.00; 0.03 | — |
| PRIMARY CFB in Activated Partial Thromboplastin Time - Part A |
24.80; 0.20; -0.25; -0.10; -1.10 | — |
| PRIMARY CFB in Prothrombin International Normalized Ratio - Part A |
1.04; 0.01; -0.03; 0.05; 0.01 | — |
| PRIMARY CFB in Prothrombin Time - Part A |
10.70; 0.00; 0.00; 0.10; -0.10 | — |
| PRIMARY CFB in Alanine Aminotransferase - Part A |
15.8; 15.3; 13.9; 7.2; 2.3 | — |
| PRIMARY CFB in Albumin - Part A |
43.2; -1.2; -0.4; -0.1; -0.3 | — |
| PRIMARY CFB in Alkaline Phosphatase - Part A |
80.6; -1.7; -2.4; -0.5; 0.0 | — |
| PRIMARY CFB in Aspartate Aminotransferase - Part A |
23.2; -0.4; -2.4; -1.0; 1.8 | — |
| PRIMARY CFB in Bicarbonate - Part A |
22.4; -0.9; 0.3; -0.1; 0.7 | — |
| PRIMARY CFB in Bilirubin - Part A |
6.082; -0.029; 0.949; 1.545; 0.543 | — |
| PRIMARY CFB in Calcium - Part A |
2.342; -0.030; 0.007; -0.014; -0.015 | — |
| PRIMARY CFB in Chloride - Part A |
100.1; 1.6; 1.1; 0.5; 0.3 | — |
| PRIMARY CFB in Creatinine - Part A |
73.254; 2.399; 4.104; 4.420; 0.118 | — |
| PRIMARY CFB in Lipase - Part A |
34.5; 16.6; 35.1; 73.3; -1.6 | — |
| PRIMARY CFB in Magnesium - Part A |
0.861; -0.012; 0.000; 0.015; 0.016 | — |
| PRIMARY CFB in Phosphate - Part A |
1.098; 0.035; 0.076; 0.083; -0.034 | — |
| PRIMARY CFB in Potassium - Part A |
4.53; -0.14; -0.08; -0.15; -0.08 | — |
| PRIMARY CFB in Protein - Part A |
69.4; -2.3; -1.5; -0.4; -1.1 | — |
| PRIMARY CFB in Sodium - Part A |
140.0; 0.8; 1.3; 0.7; 0.5 | — |
| PRIMARY CFB in Urate - Part A |
0.337; -0.005; 0.010; 0.014; -0.014 | — |
| PRIMARY CFB in Urea Nitrogen - Part A |
5.831; 0.587; 0.816; 0.663; -0.048 | — |
| PRIMARY CFB in Specific Gravity - Part A |
1.018; -0.001; 0.000; 0.002 | — |
| PRIMARY CFB in pH - Part A |
5.87; 0.18; -0.11; -0.07 | — |
| PRIMARY CFB in Temperature - Part A |
36.61; -0.04; -0.01; -0.05; -0.08; -0.06 | — |
| PRIMARY CFB in Heart Rate - Part A |
66.6; 2.1; 1.3; -0.5; -1.3; 0.8 | — |
| PRIMARY CFB in Respiratory Rate - Part A |
15.9; 0.1; 0.1; 0.0; 0.2; 0.0 | — |
| PRIMARY CFB in Supine Systolic Blood Pressure - Part A |
124.5; -6.7; -7.1; -1.5; -4.7; -4.5 | — |
| PRIMARY CFB in Standing Systolic Blood Pressure - Part A |
124.1; -3.1; -4.7; -2.9; 0.0; 2.7 | — |
| PRIMARY CFB in Supine Diastolic Blood Pressure - Part A |
77.3; -5.3; -4.7; -3.2; -3.1; -3.9 | — |
| PRIMARY CFB in Standing Diastolic Blood Pressure - Part A |
76.7; 0.4; -2.9; 0.7; 2.3; 0.9 | — |
| PRIMARY CFB in Pulse Oximetry- Part A |
96.9; -0.3; 0.2; 0.2; 0.1; -0.2 | — |
| PRIMARY CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A |
64.7; -0.5; 1.3; 6.9; 7.1; 2.5 | — |
| PRIMARY CFB in Aggregate PR Interval - Part A |
158.0; 2.0; -2.0; -2.0; -8.0; -1.0 | — |
| PRIMARY CFB in Aggregate RR Interval - Part A |
950.0; -32.5; -43.5; -99.0; -98.5; -56.0 | — |
| PRIMARY CFB in Aggregate QT Interval - Part A |
406.0; -4.0; -4.5; -9.0; -15.5; -8.5 | — |
| PRIMARY CFB in Aggregate QRS Duration - Part A |
88.0; -1.0; 0.0; 2.0; 0.0; -2.0 | — |
| PRIMARY CFB in Aggregate QTcF Interval - Part A |
419.0; -1.0; 2.0; -0.5; 6.5; -3.0 | — |
| PRIMARY CFB in Stanford Sleepiness Scale (SSS) Score - Part A |
1.2; -0.1; -0.1; -0.1; 0.0; 0.0 | — |
| 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 |
0; 0; 0; 0 | — |
| PRIMARY CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B |
19.1; -5.4; -5.9; -6.5; -6.6; -6.0 | — |
| SECONDARY MDS-UPDRS Part III Total Score - Part A |
25.4; 30.0; 34.3; 35.1; 27.1; 31.1 | — |
| SECONDARY CFB in the MDS-UPDRS Part III Total Score - Part B |
52.4; -8.4; -10.8; -11.6; -13.5; -12.4 | — |
| SECONDARY CFB in the MDS-UPDRS Part I Total Score - Part B |
9.9; -4.7; -3.9 | — |
| SECONDARY CFB in the MDS-UPDRS Part II Total Score - Part B |
15.1; -1.9; -1.7; -2.1; -2.2; -2.0 | — |
| SECONDARY CFB in the MDS-UPDRS Part I-IV Total Score - Part B |
84.6; -30.0; -24.1 | — |
| SECONDARY Percentage of Participants With TEAEs - Part B |
57.1; 0 | — |
| SECONDARY Percentage of Participants With TEAEs, Graded by Severity - Part B |
42.9; 0; 14.3; 0; 0; 0 | — |
| SECONDARY CFB in Basophils - Part B |
0.06; 0.02; 0.02; -0.03; 0.00 | — |
| SECONDARY CFB in Basophils to Leukocytes Ratio (%) - Part B |
1.0; 0.2; 0.1; -0.1; 0.1 | — |
| SECONDARY CFB in Eosinophils - Part B |
0.12; 0.05; 0.03; 0.03; -0.02 | — |
| SECONDARY CFB in Eosinophils to Leukocytes Ratio (%) - Part B |
2.0; 0.7; 0.1; 0.4; -0.4 | — |
| SECONDARY CFB in Erythrocytes - Part B |
4.65; 0.16; -0.11; -0.02; -0.06 | — |
| SECONDARY CFB in Hematocrit - Part B |
0.436; 0.023; -0.011; 0.006; -0.002 | — |
| SECONDARY CFB in Hemoglobin - Part B |
140.1; 4.9; -1.4; 1.8; -0.7 | — |
| SECONDARY CFB in Leukocytes - Part B |
6.47; 0.85; 0.31; -0.21; 0.29 | — |
| SECONDARY CFB in Lymphocytes - Part B |
1.68; 0.44; 0.26; 0.18; 0.11 | — |
| SECONDARY CFB in Lymphocytes to Leukocytes Ratio (%) - Part B |
26.0; 2.5; 2.6; 3.4; 0.6 | — |
| SECONDARY CFB in Monocytes - Part B |
0.40; 0.09; 0.03; 0.03; 0.01 | — |
| SECONDARY CFB in Monocytes to Leukocytes Ratio (%) - Part B |
6.4; 0.3; 0.1; 0.4; -0.1 | — |
| SECONDARY CFB in Neutrophils - Part B |
4.23; 0.23; 0.00; -0.43; 0.16 | — |
| SECONDARY CFB in Neutrophils to Leukocytes Ratio (%) - Part B |
65.3; -4.2; -3.0; -4.4; -0.4 | — |
| SECONDARY CFB in Platelets - Part B |
189.2; 24.1; 5.9; 0.8; 5.3 | — |
| SECONDARY CFB in Reticulocytes - Part B |
59.3; 1.1; 5.1; 2.4; 5.1 | — |
| SECONDARY CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B |
1.28; 0.04; 0.13; 0.05; 0.13 | — |
| SECONDARY CFB in Activated Partial Thromboplastin Time - Part B |
25.05; -0.40; -0.05; -0.30; -0.20 | — |
| SECONDARY CFB in Prothrombin International Normalized Ratio - Part B |
0.98; -0.03; -0.01; 0.00; 0.01 | — |
| SECONDARY CFB in Prothrombin Time - Part B |
10.60; -0.20; -0.05; -0.10; 0.10 | — |
| SECONDARY CFB in Alanine Aminotransferase - Part B |
10.0; 0.3; 2.6; 1.9; -0.2 | — |
| SECONDARY CFB in Albumin - Part B |
44.2; -0.2; -0.6; 0.16; -0.1 | — |
| SECONDARY CFB in Alkaline Phosphatase - Part B |
84.0; 1.4; 2.1; 2.2; -1.1 | — |
| SECONDARY CFB in Aspartate Aminotransferase - Part B |
17.7; -2.8; -1.4; -0.4; -2.4 | — |
| SECONDARY CFB in Bicarbonate - Part B |
24.6; -1.2; -0.9; -1.1; -0.3 | — |
| SECONDARY CFB in Bilirubin - Part B |
8.306; -2.993; -2.795; -0.122; 0.366 | — |
| SECONDARY CFB in Calcium - Part B |
2.340; 0.006; 0.002; 0.023; -0.027 | — |
| SECONDARY CFB in Chloride - Part B |
102.1; 0.1; 0.2; -0.5; -0.2 | — |
| SECONDARY CFB in Creatinine - Part B |
80.381; 11.345; 2.084; -2.968; -0.253 | — |
| SECONDARY CFB in Lipase - Part B |
37.2; 15.4; 19.4; 4.3; 1.6 | — |
| SECONDARY CFB in Magnesium - Part B |
0.873; -0.014; -0.009; 0.018; -0.012 | — |
| SECONDARY CFB in Phosphate - Part B |
1.091; 0.161; 0.180; 0.042; 0.009 | — |
| SECONDARY CFB in Potassium - Part B |
4.57; 0.03; -0.11; -0.11; -0.01 | — |
| SECONDARY CFB in Protein - Part B |
69.6; -0.8; -0.9; 0.9; -0.1 | — |
| SECONDARY CFB in Sodium - Part B |
141.8; 0.1; 0.1; 0.4; -0.1 | — |
| SECONDARY CFB in Urate - Part B |
0.291; -0.001; 0.001; 0.006; 0.007 | — |
| SECONDARY CFB in Urea Nitrogen - Part B |
5.993; 2.142; 1.275; 0.663; 0.153 | — |
| SECONDARY CFB in Specific Gravity - Part B |
1.018; 0.003; 0.001; -0.004; 0.000 | — |
| SECONDARY CFB in pH - Part B |
6.11; -0.18; -0.32; 0.39; -0.12 | — |
| SECONDARY CFB in Temperature - Part B |
36.56; -0.10; 0.01; -0.19; -0.23; -0.15 | — |
| SECONDARY CFB in Heart Rate - Part B |
72.9; 0.1; 0.1; -3.6; -1.6; 0.4 | — |
| SECONDARY CFB in Respiratory Rate - Part B |
15.6; 0.6; 0.6; 0.8; -0.9; -0.9 | — |
| SECONDARY CFB in Supine Systolic Blood Pressure - Part B |
131.7; -1.7; -1.4; 0.3; -3.3; 2.9 | — |
| SECONDARY CFB in Standing Systolic Blood Pressure - Part B |
127.8; -2.9; -2.4; 0.6; -3.4; -1.5 | — |
| SECONDARY CFB in Supine Diastolic Blood Pressure - Part B |
78.2; 0.7; 1.6; 0.6; -0.1; 1.9 | — |
| SECONDARY CFB in Standing Diastolic Blood Pressure - Part B |
81.9; -2.0; -2.4; -1.6; -3.9; -2.4 | — |
| SECONDARY CFB in Pulse Oximetry - Part B |
96.9; -0.6; 0.0; 0.4; -0.3; 0.1 | — |
| SECONDARY CFB in ECG Mean Heart Rate - Part B |
71.4; 0.1; -6.6; 0.2; -0.3; -1.6 | — |
| SECONDARY CFB in Aggregate PR Interval - Part B |
174.0; 2.5; 0.0; -2.0; -1.5; 3.5 | — |
| SECONDARY CFB in Aggregate RR Interval - Part B |
823.0; -19.0; 67.5; -32.5; -10.0; 7.0 | — |
| SECONDARY CFB in Aggregate QT Interval - Part B |
374.0; 3.5; 10.0; 2.0; 3.5; 0.0 | — |
| SECONDARY CFB in Aggregate QRS Duration - Part B |
99.5; 0.0; -1.0; -1.5; 0.0; -0.5 | — |
| SECONDARY CFB in Aggregate QTcF Interval - Part B |
407.0; 3.0; -2.5; 0.0; 0.5; -1.5 | — |
| SECONDARY Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B |
14.3; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03000569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.