Trial · NCT02978781
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
NCT02978781, Phase 2, Completed, Biogen; results first posted 2021-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate SAGE-217 in Participants With Essential Tremor. Trials, record NCT02978781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02978781
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate SAGE-217 in Participants With Essential Tremor
- NCT number
- NCT02978781
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Essential Tremor
- Interventions
- SAGE-217, SAGE-217, Placebo
- First posted
- 2016-12-01
- Last updated
- 2023-11-28
- Results first posted
- 2021-02-17
- Limitations and caveats
- Parts A and B were stopped early (in advance of the planned sample size).
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement. |
| Primary | Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 | Randomization (Day 8, predose) and Day 14 (predose) | The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement. |
| Primary | Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15 | Baseline (Day 1) and Day 15 | The accelerometer-based Kinesia upper limb total score is the sum of the individual item scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement. |
| Secondary | Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement. |
| Secondary | Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours [hr] postdose [pd]) | The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4, with higher scores indicating more tremors/greater tremor amplitude. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement. |
| Secondary | Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | The TETRAS performance subscale upper limb total score is the sum of the TETRAS individual item scores from both sides of the body. The TETRAS individual item score included TETRAS Performance Subscale item 4a, 4b and 4c scores \[4a: forward outstretched postural tremor (FOPT) and 4b: lateral "wing beating" postural tremor (LWBPT) scores and 4c: Kinetic tremor (KT) score\] from both sides of the body. Each individual item score ranges from 0 to 4; The total upper limb score ranges from 0 to 24, higher scores indicate more severe tremor. A negative change indicates improvement. |
| Secondary | Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | The TETRAS individual item score is the sum of the TETRAS Performance Subscale items 4a, 4b, or 4c scores \[4a: forward outstretched postural tremor (FOPT), 4b: lateral "wing beating" postural tremor (LWBPT), 4c: kinetic tremor\] from both sides of the body. Each TETRAS score ranges from 0 to 4; the total score ranges from 0 to 16; higher scores indicate more severe tremor. A negative change from Baseline indicates improvement. |
| Secondary | Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7 | Baseline (Day 1) and Day 7 (predose) | The TETRAS Performance Subscale score includes 9 items. Out of these 9 items, Item 6 is Archimedes spirals (AS), Item 7 is Handwriting, and Item 8 is Dot approximation task (DAT). Each item was scored from 0 to 4, for both sides of the body, each item has a total score of 0 to 8, where higher scores indicate more severe tremor. A negative change from Baseline indicates improvement. |
| Secondary | Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14 | Randomization (Day 8, predose) and Day 14 (predose) | The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement. |
| Secondary | Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14 | Randomization (Day 8, predose) and Day 14 (predose) | The accelerometer-based Kinesia upper limb total score is the sum of Kinesia kinetic tremor scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Randomization indicates improvement. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | score on a scale | MEAN |
| PRIMARY | Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 | Randomization (Day 8, predose) and Day 14 (predose) | The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation. | score on a scale | MEAN |
| PRIMARY | Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15 | Baseline (Day 1) and Day 15 | The Efficacy Population consisted of all participants who completed at least 1 dose of study drug in Part C and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours [hr] postdose [pd]) | Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7 | Baseline (Day 1) and Day 7 (8 hours postdose) | Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7 | Baseline (Day 1) and Day 7 (predose) | Efficacy population (Part A; capsules) included all participants who received at least 1 dose of SAGE-217 capsule formulation in Part A and had at least 1 postdose efficacy evaluation. Number analyzed is the number of participants with data available for analysis at the given time point. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14 | Randomization (Day 8, predose) and Day 14 (predose) | The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14 | Randomization (Day 8, predose) and Day 14 (predose) | The Efficacy Population included all participants who completed at least one dose of study drug in Part B and had at least one post-randomization efficacy evaluation. | score on a scale | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group184
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7 | Part A: SAGE-217 Capsules | Baseline (Day 1) | 4.36 | Standard Deviation 1.199 | score on a scale |
| Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7 | Part A: SAGE-217 Capsules | Change from Baseline at Day 7 (8 hours postdose) | -0.69 | Standard Deviation 1.115 | score on a scale |
| Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 | Part B: Placebo | Randomization (Day 8) | 3.33 | Standard Deviation 0.714 | score on a scale |
| Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 | Part B: SAGE-217 Capsules | Randomization (Day 8) | 4.13 | Standard Deviation 1.438 | score on a scale |
| Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 | Part B: Placebo | Change from Randomization at Day 14 (predose) | 0.20 | Standard Deviation 0.271 | score on a scale |
| Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 | Part B: SAGE-217 Capsules | Change from Randomization at Day 14 (predose) | 0.15 | Standard Deviation 0.191 | score on a scale |
| Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15 | Part C: SAGE-217 Capsules | Baseline (Day 1) | 11.68 | Standard Deviation 3.822 | score on a scale |
| Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15 | Part C: SAGE-217 Capsules | Change from Baseline at Day 15 | -2.22 | Standard Deviation 2.956 | score on a scale |
| Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7 | Part A: SAGE-217 Capsules | Baseline (Day 1) | 10.50 | Standard Deviation 4.395 | score on a scale |
| Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7 | Part A: SAGE-217 Capsules | Change from Baseline at Day 7 (8 hours postdose) | -2.40 | Standard Deviation 3.395 | score on a scale |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A: SAGE-217 Oral Solution | 2 | |
| Part A | STARTED | Part A: SAGE-217 Capsules | 14 | |
| Part A | STARTED | Part B: Placebo | 0 | |
| Part A | STARTED | Part B: SAGE-217 Capsules | 0 | |
| Part A | STARTED | Part C: SAGE-217 Capsules | 0 | |
| Part A | COMPLETED | Part A: SAGE-217 Oral Solution | 1 | |
| Part A | COMPLETED | Part A: SAGE-217 Capsules | 12 | |
| Part A | COMPLETED | Part B: Placebo | 0 | |
| Part A | COMPLETED | Part B: SAGE-217 Capsules | 0 | |
| Part A | COMPLETED | Part C: SAGE-217 Capsules | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events115
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 | Dizziness | Nervous system disorders | Part A: SAGE-217 Oral Solution | 2 | 2 | |
| other | Dizziness | Nervous system disorders | Part A: SAGE-217 Capsules | 3 | 14 | |
| other | Dizziness | Nervous system disorders | Part B: Placebo | 0 | 4 | |
| other | Dizziness | Nervous system disorders | Part B: SAGE-217 Capsules | 0 | 4 | |
| other | Dizziness | Nervous system disorders | Part C: SAGE-217 Capsules | 4 | 18 | |
| other | Somnolence | Nervous system disorders | Part A: SAGE-217 Oral Solution | 1 | 2 | |
| other | Somnolence | Nervous system disorders | Part A: SAGE-217 Capsules | 4 | 14 | |
| other | Somnolence | Nervous system disorders | Part B: Placebo | 0 | 4 | |
| other | Somnolence | Nervous system disorders | Part B: SAGE-217 Capsules | 0 | 4 | |
| other | Somnolence | Nervous system disorders | Part C: SAGE-217 Capsules | 5 | 18 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: SAGE-217 Oral Solution | 0 | 2 |
| Total, all-cause mortality | Part A: SAGE-217 Capsules | 0 | 14 |
| Total, all-cause mortality | Part B: Placebo | 0 | 4 |
| Total, all-cause mortality | Part B: SAGE-217 Capsules | 0 | 4 |
| Total, all-cause mortality | Part C: SAGE-217 Capsules | 0 | 18 |
| Total, other adverse events | Part A: SAGE-217 Oral Solution | 2 | 2 |
| Total, other adverse events | Part A: SAGE-217 Capsules | 7 | 14 |
| Total, other adverse events | Part B: Placebo | 0 | 4 |
| Total, other adverse events | Part B: SAGE-217 Capsules | 1 | 4 |
| Total, other adverse events | Part C: SAGE-217 Capsules | 10 | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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.
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