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

Summary

This is a phase 2, double-blind, placebo-controlled study to evaluate the safety and efficacy of SAGE-324 compared to placebo on upper limb (UL) tremor reduction in individuals with essential tremor (ET).

Timeline

Start

2020-05-19

Primary completion

2021-02-01

Completion

2021-02-15

Outcome

Met primary endpoint

registry p = 0.0491; Least Squares (LS) Mean Difference -1.07 (95% CI -2.14 to 0.00) NCT04305275 ↗

release “In the KINETIC Study, SAGE-324 taken orally, once daily in the morning, showed a statistically significant reduction from baseline in upper limb tremor score” biogen.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAGE-324	Unknown	60 mg	Oral

Indications