Phase 2
N=25
Evaluate SAGE-547 in Participants With Essential Tremor
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT02277106 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 12.0; 20.0; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAGE-547 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Sage Therapeutics
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
12.0; 20.0; 0; 0 | — |
| PRIMARY Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
47.1; 0 | — |
| PRIMARY Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit |
0; 4.0; 4.0; 0; 4.0; 4.0 | — |
| PRIMARY Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit |
— | — |
| PRIMARY Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure |
121.6; 120.2; -2.5; 4.0; -3.9; 3.5 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure |
125.3; -12.1; -7.6; -7.9; -6.8; -2.9 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure |
74.3; 75.0; -2.3; -0.6; -2.0; -0.7 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure |
75.5; -7.9; -6.4; -4.6; -8.8; -2.4 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate |
66.0; 69.0; -1.4; -2.1; 2.0; 1.3 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate |
69.5; 0.7; -3.3; -3.3; -1.5; -1.5 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure |
118.0; 119.1; -2.2; 1.7; -2.7; 1.0 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure |
120.1; -5.5; -5.9; -1.0; -2.9; -0.9 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure |
76.2; 78.9; -1.2; -3.1; -2.1; -2.6 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure |
78.9; -5.6; -4.5; -4.1; -4.7; -4.3 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate |
72.0; 75.6; 0.0; -1.0; 3.0; -0.0 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate |
74.6; 1.2; 0.7; -1.2; 2.6; 3.5 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Temperature |
36.62; 36.58; -0.03; 0.05; -0.04; 0.06 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Temperature |
36.64; -0.01; -0.06; 0.01; -0.02; 0.02 | — |
| PRIMARY Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate |
16.0; 16.3; 0.4; -0.2; 0.7; 0.3 | — |
| PRIMARY Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate |
16.9; -0.5; -0.4; -0.9; -0.4; 0.3 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels |
22.0; 23.3; -1.4; -2.7 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels |
23.1; 23.6 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels |
19.2; 19.0; -0.7; -0.0 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels |
15.8; 15.6 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels |
27.0; 25.2; 0.0; 1.2 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels |
26.8; 28.3 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels |
140.4; 140.2; -0.2; -0.6 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels |
139.4; 139.4 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels |
4.18; 4.17; -0.00; 0.10 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels |
4.36; 4.42 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels |
9.07; 9.08; -0.11; -0.12 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels |
9.19; 9.12 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels |
106.4; 105.8; -0.2; -0.2 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels |
103.8; 104.2 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels |
25.6; 25.6; -0.4; -0.7 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels |
26.6; 26.3 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels |
6.70; 6.66; -0.08; 0.05 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels |
7.05; 6.80 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels |
108.0; 95.4; 0.0; 19.6 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels |
108.1; 112.8 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels |
167.9; 153.1; -16.6; -0.8 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels |
162.9; 168.8 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels |
183.0; 183.4; 0.4; 2.1 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level |
194.6; 179.7 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels |
166.1; 168.4; -19.1; -25.1 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels |
162.4; 163.4 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels |
3.94; 3.95; -0.06; -0.01 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels |
4.03; 3.92 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels |
0.44; 0.47; 0.04; 0.09 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels |
0.58; 0.57 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels |
0.940; 0.951; -0.07; -0.09 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels |
0.872; 0.912 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels |
18.1; 17.9; -0.4; -0.3 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels |
17.3; 16.6 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels |
69.1; 67.1; -2.4; -0.4 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels |
71.1; 71.4 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels |
100.5; 124.0; -20.6; -36.2 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels |
83.9; 85.9 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels |
3.58; 3.52; -0.16; -0.17 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels |
3.36; 3.23 | — |
| PRIMARY Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels |
4.53; 4.71; 0.05; -0.04 | — |
| PRIMARY Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels |
4.66; 4.84 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels |
13.56; 13.63; 0.34; 0.28 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels |
14.74; 14.11 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels |
40.66; 40.97; 1.02; 0.67 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels |
45.04; 43.28 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels |
212.5; 218.8; -11.7; -7.1 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Platelet Levels |
233.8; 230.5 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels |
4.437; 4.474; 0.09; 0.07 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels |
4.925; 4.735 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels |
4.510; 4.781; -0.49; -0.66 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels |
4.049; 4.176 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels |
25.4; 27.2; 6.4; -8.3 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Basophil Levels |
35.3; 45.3 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels |
158.8; 140.3; 11.5; 42.5 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels |
87.2; 99.8 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels |
480.5; 462.8; -22.9; -40.3 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels |
499.8; 426.7 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels |
1641.7; 1590.1; 176.5; 100.3 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels |
2080.0; 1871.8 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels |
6.976; 6.972; -0.12; -0.43 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels |
6.928; 6.688 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels |
91.71; 91.72; 0.30; -0.03 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels |
91.59; 91.43 | — |
| PRIMARY Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels |
30.58; 30.90; 0.18; -0.30 | — |
| PRIMARY Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin |
29.93; 29.97 | — |
| PRIMARY Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval |
392.0; 394.0; 3.0; -2.0; -8.0; -10.0 | — |
| PRIMARY Stage 2: Change From Baseline in ECG Parameter - QT Interval |
376.0; -1.0 | — |
| PRIMARY Stage 1: Change From Baseline in ECG Parameter - PR Interval |
168.0; 170.0; 0.0; -4.0; -3.0; -2.0 | — |
| PRIMARY Stage 2: Change From Baseline in ECG Parameter - PR Interval |
144.0; 2.5 | — |
| PRIMARY Stage 1: Change From Baseline in ECG Parameter - QRS Duration |
86.0; 85.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Stage 2: Change From Baseline in ECG Parameter - QRS Duration |
90.0; 0.0 | — |
| PRIMARY Stage 1: Change From Baseline in ECG Parameter - QTcB Interval |
412.0; 413.0; -1.0; 1.0; 5.0; 0.0 | — |
| PRIMARY Stage 2: Change From Baseline in ECG Parameter - QTcB Interval |
421.0; 1.5 | — |
| PRIMARY Stage 1: Change From Baseline in ECG Parameter - QTcF Interval |
404.0; 404.0; 2.0; 0.0; 1.0; -3.0 | — |
| PRIMARY Stage 2: Change From Baseline in ECG Parameter - QTcF Interval |
406.0; 2.5 | — |
| PRIMARY Stage 1: Change From Baseline in ECG Parameter - Heart Rate |
65.0; 65.0; -1.9; 0.2; 3.3; 3.0 | — |
| PRIMARY Stage 2: Change From Baseline in ECG Parameter - Heart Rate |
72.0; -0.4 | — |
| SECONDARY Stage 1: Change From Baseline in Accelerometer Total Score Response |
7.13; 7.41; -0.96; -1.05; -0.83; -0.74 | — |
| SECONDARY Stage 2: Change From Baseline in Accelerometer Total Score Response |
6.96; -1.37; -1.25; -1.57; -1.44; -2.06 | — |
| SECONDARY Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores |
9.48; 9.72; -2.10; -2.10; -2.06; -2.72 | — |
| SECONDARY Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores |
9.24; -1.66; -2.44; -3.25; -2.66; -3.16 | — |
| SECONDARY Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score |
1.6; 1.6; 0.3; 0.0; 0.3; 0.1 | — |
| SECONDARY Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score |
1.5; 0.4; 1.4; 2.5; 3.1; 3.3 | — |
| SECONDARY Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 |
84.3 | — |
| SECONDARY Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 |
152 | — |
| SECONDARY Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 |
10 | — |
| SECONDARY Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 |
6 | — |
| SECONDARY Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 |
654 | — |
| SECONDARY Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 |
1310 | — |
| SECONDARY Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 |
716 | — |
| SECONDARY Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 |
1380 | — |
| SECONDARY Stage 1: Clearance (CL) of SAGE-547 |
1.09 | — |
| SECONDARY Stage 2: Clearance (CL) of SAGE-547 |
1.07 | — |
| SECONDARY Stage 1: Terminal Half-Life (t½) of SAGE-547 |
5.6 | — |
| SECONDARY Stage 2: Terminal Half-Life (t½) of SAGE-547 |
7.6 | — |
Summary
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb.
Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.
Eligibility Criteria
Inclusion Criteria
- Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; participant has had tremor present for at least 2 years prior to Screening
- Off medication, or on a stable dose of medication for their tremor for at least 28 days prior to Screening
Exclusion Criteria
- Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological (other than essential tremor) disorders
- Medical history of seizures
Data sourced from ClinicalTrials.gov (NCT02277106). 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.