ES-481 for Essential Tremor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ES-481 to determine its safety and tolerability for people with essential tremor, a condition causing uncontrollable shaking, usually in the hands. Participants will receive either the experimental treatment or a placebo (a pill with no active medicine) to compare results. This offers an opportunity for those who have experienced essential tremor for at least three years, affecting their daily activities, to potentially benefit from a new treatment option. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ES-481 is currently being tested for safety in treating essential tremor. Studies have found that most patients tolerate the treatment well, with no major reports of serious side effects. The drug is also under investigation for other conditions, such as epilepsy, suggesting researchers consider it fairly safe. As this trial is in an early stage, it focuses on assessing safety and how the body processes the drug. Researchers closely monitor for any side effects or issues. Overall, ES-481 appears promising in terms of safety so far.12345
Why do researchers think this study treatment might be promising for essential tremor?
Unlike the standard treatments for essential tremor, which often include beta-blockers or anti-seizure medications, ES-481 offers a novel approach. Most current therapies work by calming the nervous system overall, but ES-481 targets specific neural pathways to reduce tremors more directly. This precision could lead to fewer side effects and improved effectiveness, giving researchers hope for a more tailored and effective treatment option for those living with essential tremor.
What evidence suggests that ES-481 might be an effective treatment for essential tremor?
Research has shown that ES-481, which participants in this trial may receive, may help treat essential tremor. In earlier studies, people taking ES-481 experienced a 68% to 80% improvement in symptoms. This was significantly better than the 38% to 49% improvement in those taking a placebo (a pill with no active medicine), which serves as the comparator in this trial. The highest dose of ES-481 led to an 80% improvement, indicating strong effectiveness. These results suggest that ES-481 could be a useful treatment for essential tremor.13467
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive ES-481 or placebo with escalating doses over 4 weeks
Washout
Participants undergo a washout period between treatment periods
Treatment Period 2
Participants receive ES-481 or placebo with escalating doses over 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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)
Placebo will be dosed at the same quantity and frequency as ES-481 just as Placebo HPMC capsules
Find a Clinic Near You
Who Is Running the Clinical Trial?
ES Therapeutics Australia Pty Ltd
Lead Sponsor
Citations
Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult ...
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor.
Efficacy and Safety of ES-481, a Novel TARP Inhibitor, in ...
Subjects had 68%–80% improvements on ES-481 treatment, compared to 38%–49% under placebo treatment. For the top dose of ES-481 treatment subjects had 80% ...
ES-481 for Essential Tremor · Info for Participants
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 ...
A Systematic Review of the Literature - PMC - PubMed Central
Essential tremor (ET) is one of the most common tremor disorders in the world with an estimated incidence of 0.3% overall (increasing over the lifespan to 5% in ...
5.
aging.networkofcare.org
aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05234762?keyword=%22Tremor%22Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult ...
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor. Criteria:.
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05234762/efficacy-safety-and-pharmacokinetics-of-es-481-in-adult-patients-with-essential-tremorsEfficacy, Safety, and Pharmacokinetics of ES-481 in Adult ...
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor ...
7.
pharmaceutical-technology.com
pharmaceutical-technology.com/data-insights/es-481-es-therapeutics-epilepsy-likelihood-of-approval/ES-481 by ES Therapeutics for Epilepsy: Likelihood of ...
ES-481 (CERC-611) is under development for the treatment of essential tremor and drug resistant epilepsy. The drug candidate is administered orally.
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