Phase 2
N=16
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT02978781 ↗Enrolled (actual)
16
Serious AEs
2.4%
Results posted
Feb 2021
Primary outcome: Primary: Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7 — 4.36; -0.69 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAGE-217 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7 |
4.36; -0.69 | — |
| PRIMARY Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14 |
3.33; 4.13; 0.20; 0.15 | 0.9143 |
| PRIMARY Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15 |
11.68; -2.22 | 0.0529 |
| SECONDARY Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7 |
10.50; -2.40 | — |
| SECONDARY Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7 |
2.51; -0.74; 3.63; -0.97; 4.36 | — |
| 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 |
12.86; -4.42 | — |
| SECONDARY Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7 |
4.14; -1.46; 4.18; -1.31; 4.54; -1.65 | — |
| SECONDARY Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7 |
4.8; -1.0; 2.3; -0.4; 4.46; -0.96 | — |
| SECONDARY Part B: Change From Randomization in the Kinesia Upper Limb Total Score at Day 14 |
7.33; 9.13; 0.93; 0.55 | 0.7795 |
| SECONDARY Part B: Change From Randomization in the Kinesia Upper Limb Individual Item Score at Day 14 |
1.60; 1.85; 0.03; 0.38; 2.40; 3.15 | 0.4846 |
| SECONDARY Part B: Change From Randomization in the TETRAS Upper Limb Total Score at Day 14 |
7.88; 7.63; 1.38; 0.63 | 0.3771 |
| SECONDARY Part B: Change From Randomization in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 14 |
2.75; 2.63; 0.13; 0.00; 2.63; 2.63 | 0.7302 |
| SECONDARY Part B: Change From Randomization in the TETRAS Performance Subscale Item 4c (Kinetic Tremor) Combined Score at Day 14 |
2.50; 2.38; 0.88; 0.38 | 0.1807 |
| SECONDARY Part B: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Score at Day 14 |
5.0; 5.3; -1.3; -1.0; 2.3; 3.0 | 0.8709 |
| SECONDARY Part C: Change From Baseline in the Kinesia Upper Limb Individual Item Score at Day 15 |
2.98; -0.53; 4.41; -0.93; 4.28; -0.51 | 0.1333 |
| SECONDARY Part C: Change From Baseline in the TETRAS Upper Limb Total Score at Day 15 |
12.82; -1.60 | 0.0278 sig |
| SECONDARY Part C: Change From Baseline in the TETRAS Upper Limb Individual Item (Performance Subscale Items 4a and 4b) Score at Day 15 |
3.79; -0.13; 4.47; -0.80; 4.56; -0.67 | 0.9579 |
| SECONDARY Part C: Change From Baseline in TETRAS Performance Subscale (Items 6, 7, and 8) Scores at Day 15 |
4.5; -0.6; 2.4; -0.5; 4.25; -0.23 | 0.1595 |
| SECONDARY Parts A, B and C: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) or Serious Adverse Event (SAE) |
2; 7; 0; 1; 10; 1 | — |
| SECONDARY Part A, B and C: Number of Participants With Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Signs |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Parameters |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Values |
0; 0; 0; 0; 0 | — |
| SECONDARY Parts A and B: Change From Baseline in Stanford Sleepiness Scale (SSS) |
2.1; 1.5; 2.3; -0.2; -0.5; -0.5 | — |
| SECONDARY Parts A, B and C: Change From Baseline in Bond-Lader Visual Analogue Scale (VAS) Score |
18.737; 18.345; 21.308; 18.1248; -0.148; -2.857 | — |
| SECONDARY Parts A, B and C: Participant's Feeling After Taking the Study Drug as Assessed by Drug Effects Questionnaire (DEQ-5) Score |
54.8; 22.5; 33.0; 27.9; 21.4; 18.0 | — |
Summary
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
Eligibility Criteria
Key Inclusion Criteria
- Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.
Key Exclusion Criteria
- Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
- Participant has presence of known causes of enhanced physiological tremor.
- Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
- Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
- Participant has historical or clinical evidence of tremor with psychogenic origin.
- Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.
Data sourced from ClinicalTrials.gov (NCT02978781). 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.