← Back to Search

GABA Receptor Modulator

SAGE-324 for Essential Tremor

Phase 2 & 3
Recruiting
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Female participant has a positive pregnancy test or confirmed pregnancy or is breastfeeding.
Participant has had direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights

Summary

This trial will assess the safety of a new drug for essential tremor, a nervous system disorder that causes involuntary shaking.

Who is the study for?
This trial is for individuals with a confirmed diagnosis of Essential Tremor (ET) who have completed a previous SAGE-324 study without early termination. Participants must limit alcohol and maintain nicotine product consumption levels, be in good health excluding ET, and not use alcohol within 24 hours before clinic visits.Check my eligibility
What is being tested?
The study tests the long-term safety and tolerability of a drug called SAGE-324 in people with Essential Tremor. It aims to understand how well participants can handle the drug over an extended period.See study design
What are the potential side effects?
While specific side effects are not listed here, the trial focuses on identifying any adverse reactions or discomforts that may arise from taking SAGE-324 over time.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, confirmed by a test, and I am not breastfeeding.
Select...
I experienced a nerve injury or trauma before my tremor started.
Select...
I am allergic to SAGE-324 or its ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With at least One Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Percentage of Participants With Change from Baseline in Clinical Laboratory Parameters
Percentage of Participants With Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Responses
Percentage of Participants With Change from Baseline in Electrocardiogram (ECG) Parameters
+3 more

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

1Treatment groups
Experimental Treatment
Group I: SAGE-324 60 mgExperimental Treatment1 Intervention
Participants will receive SAGE-324 oral tablets from Day 1 to the End of Treatment (EOT) Period at a starting dose of 15 milligrams (mg). The dose will be up titrated in 15 mg increments to 60 mg. In case of intolerable adverse events, the dose will be down titrated in 15 mg decrements.
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
The most common treatments for Essential Tremor (ET) often involve modulation of neurotransmitter systems to reduce tremor severity. SAGE-324, a Positive Allosteric Modulator (PAM) of GABA-A receptors, enhances the inhibitory effects of GABA, a key neurotransmitter that reduces neuronal excitability. This mechanism is crucial for ET patients as it helps to stabilize the overactive neural circuits responsible for tremors. Other treatments, such as beta-blockers and anticonvulsants, also aim to modulate neural activity but through different pathways. Beta-blockers reduce peripheral tremor by blocking adrenaline receptors, while anticonvulsants like primidone and gabapentin modulate ion channels to stabilize neuronal firing. Understanding these mechanisms helps in tailoring treatments to effectively manage symptoms and improve the 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?

Find a Location

Who is running the clinical trial?

Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,000 Total Patients Enrolled
4 Trials studying Essential Tremor
288 Patients Enrolled for Essential Tremor

Media Library

SAGE-324 (GABA Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05366751 — Phase 2 & 3
Essential Tremor Research Study Groups: SAGE-324 60 mg
Essential Tremor Clinical Trial 2023: SAGE-324 Highlights & Side Effects. Trial Name: NCT05366751 — Phase 2 & 3
SAGE-324 (GABA Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366751 — Phase 2 & 3
Essential Tremor Patient Testimony for trial: Trial Name: NCT05366751 — Phase 2 & 3
~448 spots leftby Sep 2027