← Back to Search

Unknown

ES-481 for Essential Tremor

Phase 2
Recruiting
Research Sponsored by ES Therapeutics Australia Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be completed on days 1 (baseline and prior to administration of study medication on day 1 in treatment period 1), and days 22, 29, 44 (baseline and prior to administration of study medication on day 44 in treatment period 2), 65, and 72
Awards & highlights

Summary

This trial will study the effects of a new drug, ES-481, on patients with essential tremor. The goal is to see if it is safe and tolerated, and how it affects the body.

Who is the study for?
Adults aged 18-75 with essential tremor, not caused by other conditions or recent trauma, who haven't had surgery for tremor and are on a stable dose of anti-tremor medication. They must have no history of substance abuse or major psychiatric disorders and agree to avoid alcohol before visits.Check my eligibility
What is being tested?
The trial is testing ES-481's safety, tolerability, and how the body processes it in adults with essential tremor compared to a placebo. It's designed to see if this new treatment can help control the involuntary shaking characteristic of this condition.See study design
What are the potential side effects?
While specific side effects for ES-481 aren't listed, common side effects in trials may include nausea, headache, dizziness, fatigue or allergic reactions. Participants will be monitored closely for any adverse effects throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be completed on days 1 (baseline and prior to administration of study medication on day 1 in treatment period 1), and days 22, 29, 44 (baseline and prior to administration of study medication on day 44 in treatment period 2), 65, and 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be completed on days 1 (baseline and prior to administration of study medication on day 1 in treatment period 1), and days 22, 29, 44 (baseline and prior to administration of study medication on day 44 in treatment period 2), 65, and 72 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 abnormal laboratory test results
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P)
Plama samples for PK
+3 more
Secondary outcome measures
Activity of Daily Living
Subject Global Impression of Change Scale (SGIC)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ES-481Experimental Treatment1 Intervention
Week 1 - 25 mg qd (2 x 25 mg capsule in the mornings Days 1 to 7 in Treatment Period 1 and Days 44 to 50 in Treatment Period 2) Week 2 - 50 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 8 to 14 in Treatment Period 1 and Days 51 to 57 in Treatment Period 2) Week 3 - 75 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 15 to 21 in Treatment Period 1 and Days 58 to 64 in Treatment Period 2) Week 4 - 75 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 22 to 28 in Treatment Period 1 and Days 65 to 71 in Treatment Period 2)
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be dosed at the same quantity and frequency as ES-481 just as Placebo HPMC capsules

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) work by modulating neurological pathways to reduce tremor severity. Propranolol, a beta-blocker, decreases peripheral beta-adrenergic activity, while primidone, an anticonvulsant, enhances GABAergic inhibition. Gabapentin and topiramate also increase GABA activity and reduce excitatory signals. Botulinum toxin injections inhibit acetylcholine release, reducing muscle contractions. Deep brain stimulation (DBS) targets the thalamus to normalize electrical activity. These mechanisms are vital for ET patients as they help manage tremor symptoms, improving motor function and quality of life.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

ES Therapeutics Australia Pty LtdLead Sponsor
2 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

ES-481 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05234762 — Phase 2
Essential Tremor Research Study Groups: ES-481, Placebo
Essential Tremor Clinical Trial 2023: ES-481 Highlights & Side Effects. Trial Name: NCT05234762 — Phase 2
ES-481 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05234762 — Phase 2
~7 spots leftby Jul 2025