NCT05366751

A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor

An Open-label Study of the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 97 (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 long-term safety and tolerability of SAGE-324 in participants with essential tremor (ET).

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	SAGE-324	SAGE-324 oral tablets

Timeline

• Start date: 2022-06-03
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2022-05-09
• Last updated: 2025-08-01
• Results posted: 2025-08-01

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study