drugset / Trial / NCT02978781
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-03-24
- Primary completion
- 2017-11-22
- Completion
- 2017-12-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Part B: Placebo vs Part B: SAGE-217 Capsules; p = 0.9143; Least Squares Mean Difference 0.02 (95% CI -0.44 to 0.49); NCT02978781 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zuranolone | Small molecule | 30 mg | Oral |
| Subject | Zuranolone | Small molecule | 40 mg | Oral |