ES-481 for Essential Tremor

Overseen By Robert Niecestro, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: ES Therapeutics Australia Pty Ltd

Must be taking: Anti-tremor medications

Must not be taking: Tremorgenic drugs

Disqualifiers: Pregnancy, Alcohol dependence, Parkinson's, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 117

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a new drug called ES-481 in adults with essential tremor to see if it is safe and well-tolerated. Researchers will study how the drug moves through the body and its potential side effects.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must be on a stable dose of anti-tremor medication for at least four weeks before the study and must continue with the same dose during the study.

How does the drug ES-481 differ from other treatments for essential tremor?

ES-481 is unique because it is being specifically tested for essential tremor, whereas other treatments like propranolol and primidone are used but often have side effects or limited effectiveness. Unlike deep brain stimulation, which is a surgical option, ES-481 offers a non-invasive approach, potentially providing a new alternative for patients who do not respond well to existing medications. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with essential tremor which means you have been experiencing shaking in your arms for at least three years, even when you are trying to do something. You may have shaking in other parts of your body as well.

You have never taken perampanel before.

The Subject must have Essential Tremor (ET). ET is defined as at least 1 upper extremity with a tremor score ≥ 1.5 in forward posture, wing beating posture, or finger-to-nose movement using the Performance subscale of The Essential Tremor Rating Assessment Scale (as per by the Tremor Investigation Group criteria).

Exclusion Criteria

You are using an intrauterine device for birth control.

You have had a surgery to permanently prevent pregnancy.

You have experienced nerve system injury or trauma within the last 3 months prior to the start of your tremors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive ES-481 or placebo with escalating doses over 4 weeks

4 weeks

Visits on Days 1, 8, 15, 22

Washout

Participants undergo a washout period between treatment periods

2 weeks

Treatment Period 2

Participants receive ES-481 or placebo with escalating doses over 4 weeks

4 weeks

Visits on Days 44, 51, 58, 65

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Visit on Day 72

Treatment Details

Interventions

• ES-481
• Placebo

Trial Overview 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.

Participant Groups

Group I: ES-481 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Placebo will be dosed at the same quantity and frequency as ES-481 just as Placebo HPMC capsules

Who Is Running the Clinical Trial?

ES Therapeutics Australia Pty Ltd

Lead Sponsor

Trials

3

Recruited

50+

References

1. United States pubmed.ncbi.nlm.nih.gov

Objective response to ethanol in essential tremor: results from a standardized ethanol challenge study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pregabalin (Lyrica) in the treatment of essential tremor. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Treatment of essential tremor: a systematic review of evidence and recommendations from the Italian Movement Disorders Association. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Treatment of patients with essential tremor. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Gabapentin for essential tremor: a multiple-dose, double-blind, placebo-controlled trial. [2019]