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Study to Evaluate SAGE-324 in Participants With Essential Tremor

NCT05173012 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-05-16

Study results available
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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

Interventions

DRUG

SAGE-324

SAGE-324 oral tablets.

DRUG

SAGE-324 Matched Placebo

SAGE-324 matched placebo oral tablets.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • 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
2022-01-05
Primary Completion
2024-05-02
Completion
2024-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05173012 on ClinicalTrials.gov