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

NCT04305275 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-04-17

Study results available
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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).

Conditions

Interventions

DRUG

SAGE-324

SAGE-324 oral tablet

DRUG

SAGE-324 Placebo

SAGE-324 matched placebo oral tablet

Sponsors & Collaborators

  • Sage Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-19
Primary Completion
2021-02-01
Completion
2021-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305275 on ClinicalTrials.gov