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GABA receptor modulator

SAGE-324 for Essential Tremor

Phase 2
Waitlist Available
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of other neurological signs, such as dystonia, ataxia, or parkinsonism, isolated focal tremors (eg, voice, head), task- and position-specific tremors, sudden tremor onset, or evidence of stepwise deterioration of tremor.
Scores of at least 12 in the combined TETRAS Performance Subscale Item 4 (upper limb tremor) at both Screening and pre-dose on Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 91
Awards & highlights

Study Summary

This trial is testing different doses of SAGE-324 to see how it affects upper extremity tremor in people with essential tremors.

Who is the study for?
This trial is for adults with Essential Tremor (ET) that's lasted at least 3 years. Participants must be willing to stop their ET medications before starting the study, except propranolol if it's been taken steadily. They can't have other neurological issues or use certain treatments like the Cala Trio bracelet, and they shouldn't have a history of substance abuse or dependence.Check my eligibility
What is being tested?
The trial tests SAGE-324 against a placebo to see how different doses affect arm tremors in people with ET. It looks at whether one dose works better than another when no other tremor medications are used.See study design
What are the potential side effects?
Possible side effects aren't specified here, but generally, participants might experience reactions related to the nervous system due to the nature of SAGE-324 targeting tremors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have other major nerve system symptoms like uncontrolled movements or balance issues.
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My upper limb tremor score is 12 or more.
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My dominant arm's function scores at least 6 on a specific test.
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I have been diagnosed with Essential Tremor in my arms for over 3 years, with no other major neurological issues.
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I have been diagnosed with Essential Tremor in my arms for at least 3 years.
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My upper limb tremor score is 12 or more.
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My arm strength score is 6 or more.
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I can perform most daily activities by myself.
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I am willing to stop my essential tremor medications except propranolol before starting the trial.
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I agree to limit my alcohol intake and keep my nicotine use the same as before the study.
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I have been on a stable dose of propranolol for ET treatment for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 91
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 91 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Total Score on Day 91 in the Monotherapy Cohort
Secondary outcome measures
Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAGE-324 60 mgExperimental Treatment1 Intervention
Participants will receive SAGE-324: 15 mg, 30 mg, 45 mg, and 60 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
Group II: SAGE-324 30 mgExperimental Treatment1 Intervention
Participants will receive SAGE-324, 30 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
Group III: SAGE-324 15 mgExperimental Treatment1 Intervention
Participants will receive SAGE-324, 15 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
Group IV: SAGE-324 Matched PlaceboPlacebo Group1 Intervention
Participants will receive SAGE-324 matched placebo, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324 matched placebo, oral tablets, once daily (QD), in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324 matched placebo, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 milligrams (mg) of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAGE-324
2020
Completed Phase 2
~70

Who is running the clinical trial?

BiogenIndustry Sponsor
639 Previous Clinical Trials
467,274 Total Patients Enrolled
1 Trials studying Essential Tremor
34 Patients Enrolled for Essential Tremor
Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,601 Total Patients Enrolled
4 Trials studying Essential Tremor
878 Patients Enrolled for Essential Tremor

Media Library

SAGE-324 (GABA receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05173012 — Phase 2
Essential Tremor Research Study Groups: SAGE-324 30 mg, SAGE-324 Matched Placebo, SAGE-324 60 mg, SAGE-324 15 mg
Essential Tremor Clinical Trial 2023: SAGE-324 Highlights & Side Effects. Trial Name: NCT05173012 — Phase 2
SAGE-324 (GABA receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05173012 — Phase 2
Essential Tremor Patient Testimony for trial: Trial Name: NCT05173012 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many geographic sites has this clinical trial been instituted in?

"Presently, this research project is attempting to secure patients from 21 medical centres. Cincinnati, Dayton and Las Vegas are among the most prominent locations; however there are 18 other sites close by that may be convenient for potential participants."

Answered by AI

To what extent is the population being scrutinized in this research study?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial, which was initially uploaded on January 24th 2022, is currently recruiting patients. 160 individuals across 21 sites need to be enrolled in the study."

Answered by AI

Has the federal government given clearance to SAGE-324?

"The safety rating of SAGE-324 is a 2 since this Phase 2 trial has accumulated evidence to attest its security but not sufficient proof regarding efficacy yet."

Answered by AI

Who meets the criteria for inclusion in this experiment?

"This medical study is searching for 160 participants aged 18 to 80 with familial tremor. In order to be accepted, potential volunteers must have a combined TETRAS Performance Subscale Item 4 score of 12 at pre-screening and Day 1 before the dose, as well as 6 in their total dominant upper limb score from both checkpoints. Additionally, patients must discontinue any medications taken for ET treatment 14 days or longer (depending on half life) prior to receiving IP and they cannot show signs of other neurological conditions like dystonia, parkinsonism, etc."

Answered by AI

Is this research project currently seeking participants?

"As per the latest update on clinicaltrials.gov, this medical study is still enrolling volunteers. The trial was first posted in late January of 2022 and has been amended as recently as September 7th of the same year."

Answered by AI

Does this trial accept applicants of advanced age?

"To be eligible for this medical trial, patients must have their 18th birthdays but not yet celebrated their 80th. Separate trials are available to those younger than 18 and older than 65 years of age; the latter requires 50 participants."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Missouri
Illinois
Other
How old are they?
18 - 65
What site did they apply to?
Sage Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

Head ET has progressed to dominate hand arm. Eating and drinking difficult.
PatientReceived 2+ prior treatments
The condition has spread to my right upper arms. I'm concerned it will get worse.
PatientReceived 1 prior treatment
i have been diagnosed with essential tremors in my hands and it appears to be increasing.
PatientReceived no prior treatments
I've used Propramolol but think there could be something that can help me more. My father had tremors, and 3 of my children have them.
PatientReceived 1 prior treatment
My tremors are becoming increasingly bothersome. I’ve had to quit certain activities and scale back others. I am always frustrated by my tremors.
PatientReceived 2+ prior treatments
~51 spots leftby Mar 2025