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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 6 in the total TETRAS Performance Subscale Item 4 score for the dominant upper limb (the sum of the three items for either the right or left upper limb, whichever is dominant) at both Screening and pre-dose on Day 1
Must not have
Previous procedure for the treatment of ET such as deep brain stimulation, brain lesioning, or magnetic resonance (MR) guided procedure
Use of Cala Trio bracelet for the treatment of ET from two weeks prior to Day 1 through Day 97
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 91
Awards & highlights

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 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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I can perform most daily activities by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone a procedure like deep brain stimulation for essential tremor.
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I have been using the Cala Trio bracelet for my ET for at least two weeks.
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I have tremors due to a functional neurological condition.
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I am currently taking propranolol for a condition that is not essential tremor.

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

Side effects data

From 2021 Phase 2 trial • 69 Patients • NCT04305275
68%
Somnolence
38%
Dizziness
15%
Balance disorder
15%
Fatigue
12%
Diplopia
12%
Dysarthria
12%
Gait disturbance
9%
Disturbance in attention
9%
Myoclonus
6%
Diarrhoea
6%
Speech disorder
6%
Lethargy
6%
Paraesthesia
6%
Mental status changes
3%
Headache
3%
Coordination abnormal
3%
Urinary tract infection
3%
Transient ischaemic attack
3%
Dehydration
3%
Asthenia
3%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAGE-324 Matched Placebo
SAGE-324 60 mg

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Essential Tremor (ET) treatments often target the modulation of neurotransmitter systems to reduce tremor severity. SAGE-324, a Positive Allosteric Modulator of GABA-A receptors, enhances the inhibitory effects of GABA, leading to reduced neuronal excitability and tremor. This mechanism is crucial for ET patients as it directly addresses the hyperactivity in the central nervous system that contributes to tremor. Other common treatments include beta-blockers like propranolol, which reduce tremor by blocking peripheral adrenergic receptors, and anticonvulsants like primidone, which also enhance GABAergic activity. Understanding these mechanisms helps in tailoring treatments to effectively manage symptoms and improve quality of life for ET patients.
[On the central inhibition action of tetrahydroberberine without relevance to GABA receptors].The ups and downs of alkyl-carbamates in epilepsy therapy: How does cenobamate differ?Are Type 1 metabotropic glutamate receptors a viable therapeutic target for the treatment of cerebellar ataxia?

Who is running the clinical trial?

BiogenIndustry Sponsor
640 Previous Clinical Trials
466,961 Total Patients Enrolled
1 Trials studying Essential Tremor
34 Patients Enrolled for Essential Tremor
Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,590 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 60 mg, SAGE-324 30 mg, SAGE-324 Matched Placebo, 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
~46 spots leftby Jul 2025