What side effects are associated with this type of intervention?

Common treatments for Essential Tremor include beta-blockers like propranolol, anticonvulsants such as primidone, and benzodiazepines like clonazepam. Side effects of these treatments can include fatigue, dizziness, nausea, and cognitive impairment. For treatments similar to SAGE-324, which modulate GABA-A receptors, side effects may include sedation, dizziness, and potential dependency with long-term use. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved Positive Allosteric Modulators of GABA-A receptors for the treatment of Essential Tremor. However, other treatments for Essential Tremor include medications like propranolol and primidone, which are commonly used. Additionally, surgical options such as thalamotomy and deep brain stimulation have shown efficacy in managing symptoms. The ongoing study of SAGE-324 aims to evaluate its long-term safety and tolerability, potentially offering a new therapeutic option targeting GABA-A receptors.

What other types of research exist?

Promising novel alternatives to SAGE-324 for Essential Tremor patients include: 1) Cala Trio, a non-invasive neuromodulation device that delivers electrical stimulation to the wrist, 2) Focused Ultrasound Thalamotomy, a non-invasive surgical procedure targeting the thalamus, and 3) TMS (Transcranial Magnetic Stimulation), which uses magnetic fields to stimulate nerve cells in the brain. These alternatives offer different mechanisms of action and have shown potential in clinical studies.

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GABA Receptor Modulator

SAGE-324 for Essential Tremor

Phase 2 & 3

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

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

No Placebo-Only Group

Summary

This trial is testing a new medication called SAGE-324 to see if it is safe and can be tolerated by people with essential tremor over several months.

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.

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.

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:

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I am not pregnant, confirmed by a test, and I am not breastfeeding.

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I experienced a nerve injury or trauma before my tremor started.

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I am allergic to SAGE-324 or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With at least One Treatment-Emergent Adverse Events (TEAEs)

Secondary study objectives

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 Epworth Sleepiness Scale (ESS) Score

+2 more

Side effects data

From 2021 Phase 2 trial • 69 Patients • NCT04305275

68%

Somnolence

38%

Dizziness

15%

Balance disorder

15%

Fatigue

12%

Gait disturbance

12%

Diplopia

12%

Dysarthria

Myoclonus

Disturbance in attention

Mental status changes

Diarrhoea

Lethargy

Speech disorder

Paraesthesia

Headache

Insomnia

Asthenia

Dehydration

Urinary tract infection

Transient ischaemic attack

Coordination abnormal

100%

80%

60%

40%

20%

Study treatment Arm

SAGE-324 Matched Placebo

SAGE-324 60 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

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.

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