Evaluate SAGE-547 in Participants With Essential Tremor

Summary

Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb. Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.

Timeline

Start

2014-09-23

Primary completion

2015-08-14

Completion

2015-08-14

Publications

• Results Aaron Ellenbogen, Shane Raines, Stephen Kanes. Exploratory trial results for SAGE-547 in essential tremor. Presented at AAN, April 19, 2016 P4.297. MRC-ZUL-00141_Exploratory Trial Results for SAGE-547 in Essential Tremor.

Drugs

Indications