What side effects are associated with this type of intervention?

Common treatments for Essential Tremor that modulate neurological pathways include beta blockers (e.g., propranolol), anticonvulsants (e.g., primidone, gabapentin, topiramate), and neuromodulation techniques. Propranolol can cause fatigue, dizziness, and depression. Primidone may lead to sedation, vertigo, ataxia, and confusion. Gabapentin's side effects include sleepiness, dizziness, and gait unsteadiness, particularly in older adults. Topiramate is associated with a high rate of adverse effects such as cognitive impairment and weight loss. Neuromodulation techniques, while generally safe, can cause transient side effects like numbness or paresthesia. These side effects should be discussed with a healthcare provider to tailor the best treatment plan for ET.

What prior FDA approvals exist?

The FDA has approved several treatments for Essential Tremor that modulate neurological pathways. Notably, propranolol and primidone are commonly used first-line treatments. Additionally, neuromodulation devices and techniques such as noninvasive median and radial nerve stimulation have shown promise in clinical studies. While specific FDA approvals for drugs similar to ES-481 are not detailed, ongoing research and trials, including those for octanoic acid and other neuromodulation therapies, indicate a focus on targeting neurological pathways to manage tremor symptoms.

What other types of research exist?

Promising, novel alternatives to ES-481 for Essential Tremor patients include nimodipine, which has shown effectiveness in some patients, and surgical options such as focused ultrasound thalamotomy and gamma knife thalamotomy, which have demonstrated functional improvements in tremor management.

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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

Summary

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.

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.

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.

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 weeks3 visits

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

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

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

Primary study objectives

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 study objectives

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

Do I qualify?Apply below to find out

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.