Study to Evaluate SAGE-324 in Participants With Essential Tremor
Summary
The primary purpose of this study is to evaluate the dose-response relationship of different doses of SAGE-324 on upper extremity tremor in participants with essential tremor (ET) in the monotherapy cohort.
Timeline
- Start
- 2022-01-05
- Primary completion
- 2024-05-02
- Completion
- 2024-05-16
Outcome
Missed primary endpoint
registry Monotherapy: Placebo vs Monotherapy: SAGE-324 15 mg; p = 0.5325; Least Squares (LS) Mean Difference 0.39 (95% CI -0.84 to 1.62) NCT05173012 ↗
registry Monotherapy: Placebo vs Monotherapy: SAGE-324 30 mg; p = 0.6549; LS Mean Difference -0.28 (95% CI -1.54 to 0.97) NCT05173012 ↗
registry Monotherapy: Placebo vs Monotherapy: SAGE-324 60 mg; p = 0.1462; LS Mean Difference 1.02 (95% CI -0.36 to 2.41) NCT05173012 ↗
release “The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint” biogen.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAGE-324 | Unknown | 15 mg | Oral |
| Subject | SAGE-324 | Unknown | 30 mg | Oral |
| Subject | SAGE-324 | Unknown | 60 mg | Oral |