NCT05173012

Study to Evaluate SAGE-324 in Participants With Essential Tremor

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Sage Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	SAGE-324	SAGE-324 oral tablets.
DRUG	SAGE-324 Matched Placebo	SAGE-324 matched placebo oral tablets.

Timeline

• Start date: 2022-01-05
• Primary completion: 2024-05-02
• Completion: 2024-05-16
• First posted: 2021-12-29
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study