NCT02277106 is a Phase 2 clinical trial of SAGE-547 in Essential Tremor, sponsored by Sage Therapeutics.

Who is sponsoring NCT02277106?

NCT02277106 is sponsored by Sage Therapeutics.

What drugs are being tested in NCT02277106?

Interventions in NCT02277106: SAGE-547, Placebo.

What condition does NCT02277106 study?

NCT02277106 studies Essential Tremor.

Is NCT02277106 still recruiting?

NCT02277106 is currently completed. Last updated 29 June 2022.

Are results published for NCT02277106?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-06-29 · How we verify

NCT02277106

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate SAGE-547 in Participants With Essential Tremor

Completed Phase 2 Results posted Last updated 29 June 2022

What this trial tests

Phase 2 trial testing SAGE-547 in Essential Tremor in 25 participants. Completed in 14 August 2015.

Timeline

23 September 2014

Primary endpoint
14 August 2015

14 August 2015

Quick facts

Lead sponsor	Sage Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	25
Start date	23 September 2014
Primary completion	14 August 2015
Estimated completion	14 August 2015
Sites	2 locations across United States

Drugs / interventions tested

SAGE-547 — full drug profile →
Placebo

Conditions studied

Essential Tremor — all drugs for Essential Tremor →

Sponsor

Sage Therapeutics — full company profile →

Who can join

Adults 35 to 75, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Stage 1: Up to 30 days after last infusion (up to Day 40)

An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medi

TEAEs

Group	Value	95% CI
Stage 1: SAGE-547	12.0
Stage 1: Placebo	20.0

SAEs

Group	Value	95% CI
Stage 1: SAGE-547	0
Stage 1: Placebo	0

Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Stage 2: Up to 30 days after last infusion (up to Day 31)

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important

TEAEs

Group	Value	95% CI
Stage 2: SAGE-547	47.1

SAEs

Group	Value	95% CI
Stage 2: SAGE-547	0

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 Primary · Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2)

The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) witho

Suicidal Ideation: Wish to be Dead: Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	0
Stage 1: Placebo	4.0

Suicidal Ideation: Non-specific Active Suicidal Thoughts: Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	4.0
Stage 1: Placebo	0

Suicidal Behavior: Actual Attempt: Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	4.0
Stage 1: Placebo	4.0

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 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion

The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with som

Group	Value	95% CI
Stage 2: SAGE-547	0

Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure Primary · Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	121.6	± 11.58
Stage 1: Placebo	120.2	± 15.47

CFB at 4 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-2.5	± 10.84
Stage 1: Placebo	4.0	± 11.71

CFB at 8 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-3.9	± 11.64
Stage 1: Placebo	3.5	± 10.24

CFB at 12 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-1.6	± 10.44
Stage 1: Placebo	7.6	± 10.14

CFB at 12-hour Follow-up

Group	Value	95% CI
Stage 1: SAGE-547	5.6	± 8.68
Stage 1: Placebo	1.4	± 11.85

Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure Primary · Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion

Pre-infusion

Group	Value	95% CI
Stage 2: SAGE-547	125.3	± 13.22

CFB at 2 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-12.1	± 14.95

CFB at 4 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-7.6	± 17.12

CFB at 6 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-7.9	± 14.01

CFB at 8 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-6.8	± 17.44

CFB at 10 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-2.9	± 13.48

CFB at 12 Hours

Group	Value	95% CI
Stage 2: SAGE-547	4.0	± 13.22

CFB at 14 Hours

Group	Value	95% CI
Stage 2: SAGE-547	3.1	± 18.44

Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure Primary · Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	74.3	± 8.90
Stage 1: Placebo	75.0	± 11.24

CFB at 4 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-2.3	± 9.85
Stage 1: Placebo	-0.6	± 6.10

CFB at 8 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-2.0	± 6.79
Stage 1: Placebo	-0.7	± 8.27

CFB at 12 Hours

Group	Value	95% CI
Stage 1: SAGE-547	0.4	± 8.33
Stage 1: Placebo	1.2	± 9.69

CFB at 12-hour Follow-up

Group	Value	95% CI
Stage 1: SAGE-547	2.0	± 8.17
Stage 1: Placebo	0.8	± 9.68

Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure Primary · Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 2: SAGE-547	75.5	± 7.63

CFB at 2 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-7.9	± 8.59

CFB at 4 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-6.4	± 10.20

CFB at 6 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-4.6	± 9.70

CFB at 8 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-8.8	± 10.17

CFB at 10 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-2.4	± 9.52

CFB at 12 Hours

Group	Value	95% CI
Stage 2: SAGE-547	0.3	± 8.80

CFB at 14 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-2.2	± 9.03

Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate Primary · Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	66.0	± 9.70
Stage 1: Placebo	69.0	± 12.99

CFB at 4 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-1.4	± 7.52
Stage 1: Placebo	-2.1	± 10.39

CFB at 8 Hours

Group	Value	95% CI
Stage 1: SAGE-547	2.0	± 6.37
Stage 1: Placebo	1.3	± 14.85

CFB at 12 Hours

Group	Value	95% CI
Stage 1: SAGE-547	5.0	± 8.67
Stage 1: Placebo	2.1	± 11.23

CFB at 12-hour Follow-up

Group	Value	95% CI
Stage 1: SAGE-547	2.9	± 9.17
Stage 1: Placebo	-2.3	± 8.96

Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate Primary · Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 2: SAGE-547	69.5	± 10.96

CFB at 2 Hours

Group	Value	95% CI
Stage 2: SAGE-547	0.7	± 10.18

CFB at 4 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-3.3	± 7.22

CFB at 6 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-3.3	± 10.30

CFB at 8 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-1.5	± 9.00

CFB at 10 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-1.5	± 9.10

CFB at 12 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-2.1	± 8.55

CFB at 14 Hours

Group	Value	95% CI
Stage 2: SAGE-547	3.9	± 10.29

Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure Primary · Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 1: SAGE-547	118.0	± 17.27
Stage 1: Placebo	119.1	± 15.00

CFB at 4 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-2.2	± 10.70
Stage 1: Placebo	1.7	± 12.48

CFB at 8 Hours

Group	Value	95% CI
Stage 1: SAGE-547	-2.7	± 13.23
Stage 1: Placebo	1.0	± 12.87

CFB at 12 Hours

Group	Value	95% CI
Stage 1: SAGE-547	2.0	± 12.65
Stage 1: Placebo	7.8	± 11.48

CFB at 12-hour Follow-up

Group	Value	95% CI
Stage 1: SAGE-547	5.0	± 15.82
Stage 1: Placebo	1.7	± 10.76

Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure Primary · Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion

Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.

Pre-infusion

Group	Value	95% CI
Stage 2: SAGE-547	120.1	± 13.05

CFB at 2 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-5.5	± 15.98

CFB at 4 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-5.9	± 13.87

CFB at 6 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-1.0	± 16.84

CFB at 8 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-2.9	± 14.22

CFB at 10 Hours

Group	Value	95% CI
Stage 2: SAGE-547	-0.9	± 16.49

CFB at 12 Hours

Group	Value	95% CI
Stage 2: SAGE-547	10.2	± 17.28

CFB at 14 Hours

Group	Value	95% CI
Stage 2: SAGE-547	11.1	± 18.98

Adverse events — posted to ClinicalTrials.gov

Time frame: Stage 1: Up to 30 days after last infusion (up to Day 40); Stage 2: Up to 30 days after last infusion (up to Day 31). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stage 1: SAGE-547

Serious: 0/25 (0%)

Deaths: 0/25

Stage 1: Placebo

Serious: 0/25 (0%)

Deaths: 0/25

Stage 2: SAGE-547

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (7 terms — click to expand)

Reaction	System	Stage 1: SAGE-547	Stage 1: Placebo	Stage 2: SAGE-547
Fatigue	General disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Sedation	Nervous system disorders	—	—	—
Hypotension	Vascular disorders	—	—	—

Data from ClinicalTrials.gov NCT02277106 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging strategies in the management of essential tremor.
Hedera P. · · 2017 · cited 24× · PMID 28382111 · DOI 10.1177/1756285616679123
Essential Tremor: What We Can Learn from Current Pharmacotherapy.
Ondo W. · · 2016 · cited 13× · PMID 26989572 · DOI 10.7916/d8k35tc3

Verify or expand the search:

Other trials of SAGE-547

Trials testing the same drug.

NCT02614547 — A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression · Phase 2 · completed
NCT02285504 — Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression · Phase 2 · completed
NCT02052739 — Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus · Phase 1, PHASE2 · completed
NCT02433314 — An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus · no longer available

Other recruiting trials for Essential Tremor

Currently open trials in the same condition.

NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
NCT07172295 — Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With R · NA · recruiting
NCT07016425 — Temporal Interference for Essential Tremor · NA · recruiting
NCT07049003 — Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor · Phase 1 · recruiting
NCT06428526 — Impact of Sensory Electrical Stimulation on Sensation and Tremor · NA · active not recruiting

Other Sage Therapeutics trials

Trials by the same sponsor.

NCT05366751 — A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor · Phase 2, PHASE3 · terminated
NCT05173012 — Study to Evaluate SAGE-324 in Participants With Essential Tremor · Phase 2 · completed
NCT04537806 — A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) · Phase 3 · terminated
NCT04305275 — A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02277106 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sage Therapeutics
Last refreshed: 29 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02277106.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02277106

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of SAGE-547

Other recruiting trials for Essential Tremor

Other Sage Therapeutics trials

Verify against primary sources