Trial · NCT02277106
Evaluate SAGE-547 in Participants With Essential Tremor
NCT02277106, Phase 2, Completed, Sage Therapeutics; results first posted 2022-06-29
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ConductScience Library. Evaluate SAGE-547 in Participants With Essential Tremor. Trials, record NCT02277106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02277106
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate SAGE-547 in Participants With Essential Tremor
- NCT number
- NCT02277106
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Sage Therapeutics
- Conditions
- Essential Tremor
- Interventions
- SAGE-547, Placebo
- First posted
- 2014-10-28
- Last updated
- 2022-06-29
- Results first posted
- 2022-06-29
Source ClinicalTrials.gov
Registered outcomes116
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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 medically important condition. |
| Primary | Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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 condition. |
| 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 | 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) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported. |
| 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 | 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 some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. |
| Primary | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | 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. |
| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | 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 systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | 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. |
| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | 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. |
| Primary | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | 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. |
| Primary | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | 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. |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 registered outcomesOutcomes116
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 1: Up to 30 days after last infusion (up to Day 40) | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | percentage of participants | NUMBER |
| PRIMARY | Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 2: Up to 30 days after last infusion (up to Day 31) | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | percentage of participants | NUMBER |
| 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 | Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2) | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | percentage of participants | NUMBER |
| 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 | Stage 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. | percentage of participants | NUMBER |
| PRIMARY | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | 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 | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | mmHg | MEAN |
| PRIMARY | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | 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 | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | mmHg | MEAN |
| PRIMARY | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | mmHg | MEAN |
| PRIMARY | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | 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 | Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. | beats per minute (bpm) | MEAN |
| PRIMARY | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point. | bpm | MEAN |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 outcomesResults by group518
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 1: SAGE-547 | TEAEs | 12.0 | percentage of participants | |
| Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 1: Placebo | TEAEs | 20.0 | percentage of participants | |
| Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 1: SAGE-547 | SAEs | 0 | percentage of participants | |
| Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 1: Placebo | SAEs | 0 | percentage of participants | |
| Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 2: SAGE-547 | TEAEs | 47.1 | percentage of participants | |
| Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 2: SAGE-547 | SAEs | 0 | percentage of participants | |
| 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 | Stage 1: SAGE-547 | Suicidal Ideation: Wish to be Dead: Pre-infusion | 0 | percentage of participants | |
| 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 | Stage 1: Placebo | Suicidal Ideation: Wish to be Dead: Pre-infusion | 4.0 | percentage of participants | |
| 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 | Stage 1: SAGE-547 | Suicidal Ideation: Non-specific Active Suicidal Thoughts: Pre-infusion | 4.0 | percentage of participants | |
| 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 | Stage 1: Placebo | Suicidal Ideation: Non-specific Active Suicidal Thoughts: Pre-infusion | 0 | percentage of participants |
1 to 10 of 518Source ClinicalTrials.gov
See all 518 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1: Treatment Period 1 | STARTED | Stage 1 (Double-blind): SAGE 547, Then Placebo | 13 | |
| Stage 1: Treatment Period 1 | STARTED | Stage 1 (Double-blind): Placebo, Then SAGE-547 | 12 | |
| Stage 1: Treatment Period 1 | STARTED | Stage 2 (Open Label): SAGE-547 | 0 | |
| Stage 1: Treatment Period 1 | COMPLETED | Stage 1 (Double-blind): SAGE 547, Then Placebo | 13 | |
| Stage 1: Treatment Period 1 | COMPLETED | Stage 1 (Double-blind): Placebo, Then SAGE-547 | 12 | |
| Stage 1: Treatment Period 1 | COMPLETED | Stage 2 (Open Label): SAGE-547 | 0 | |
| Stage 1: Treatment Period 1 | NOT COMPLETED | Stage 1 (Double-blind): SAGE 547, Then Placebo | 0 | |
| Stage 1: Treatment Period 1 | NOT COMPLETED | Stage 1 (Double-blind): Placebo, Then SAGE-547 | 0 | |
| Stage 1: Treatment Period 1 | NOT COMPLETED | Stage 2 (Open Label): SAGE-547 | 0 | |
| Washout | STARTED | Stage 1 (Double-blind): SAGE 547, Then Placebo | 13 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Stage 1: SAGE-547 | 1 | 25 | |
| other | Fatigue | General disorders | Stage 1: Placebo | 0 | 25 | |
| other | Fatigue | General disorders | Stage 2: SAGE-547 | 4 | 17 | |
| other | Hyperbilirubinaemia | Hepatobiliary disorders | Stage 1: SAGE-547 | 0 | 25 | |
| other | Hyperbilirubinaemia | Hepatobiliary disorders | Stage 1: Placebo | 0 | 25 | |
| other | Hyperbilirubinaemia | Hepatobiliary disorders | Stage 2: SAGE-547 | 1 | 17 | |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Stage 1: SAGE-547 | 0 | 25 | |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Stage 1: Placebo | 0 | 25 | |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Stage 2: SAGE-547 | 1 | 17 | |
| other | Dizziness | Nervous system disorders | Stage 1: SAGE-547 | 0 | 25 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: SAGE-547 | 0 | 25 |
| Total, all-cause mortality | Stage 1: Placebo | 0 | 25 |
| Total, all-cause mortality | Stage 2: SAGE-547 | 0 | 17 |
| Total, other adverse events | Stage 1: SAGE-547 | 1 | 25 |
| Total, other adverse events | Stage 1: Placebo | 3 | 25 |
| Total, other adverse events | Stage 2: SAGE-547 | 8 | 17 |
| Total, serious adverse events | Stage 1: SAGE-547 | 0 | 25 |
| Total, serious adverse events | Stage 1: Placebo | 0 | 25 |
| Total, serious adverse events | Stage 2: SAGE-547 | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02277106
GET https://conductscience.org/api/trials/v1/NCT02277106/registered?page=2