Your session is about to expire
← 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
Study 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 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
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 moreSecondary 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
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
Eligibility Criteria:
This trial includes the following eligibility 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.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.You have a history of tremors caused by psychological issues like eating disorders or depression.You have attempted suicide in the past two years or are currently at risk of harming yourself, according to the investigator.You have undergone a previous procedure to treat ET or any brain-related procedures like deep brain stimulation, brain lesioning or magnetic resonance-guided procedure.You have used illegal drugs or are addicted to alcohol within the last year, or have tested positive for drugs or alcohol during the screening or the first day of the study.You have had seizures as an adult, suffered a head injury or a stroke in the last year, or had unexplained fainting in the last year. You have also experienced dizziness or fainting when standing up.You are taking more than three medications to treat essential tremors at the same time.You have a history of substance addiction based on DSM-5 criteria, as determined by the Principal Investigator.You do not have any medical, neurological, or psychiatric conditions that could cause tremors, such as Parkinson's disease, Huntington's disease, traumatic brain injury, or substance abuse.You are allergic to ES-481 or any of its ingredients.You have not had any botulinum injections for at least six months before screening.You are pregnant or currently breastfeeding.You must use condoms or diaphragms with spermicide during the study.You have any other neurological condition other than essential tremor, like dystonia, ataxia or multiple sclerosis.You have been diagnosed with essential tremor, meaning you have shaking in your hands that has lasted for at least three years, and may or may not have shaking in other parts of your body.
Research Study Groups:
This trial has the following groups:- Group 1: ES-481
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project open to people who are below the age of 60?
"The age range that is able to enroll in this research project spans from 18 years old to 75 years old."
Answered by AI
How many individuals are being asked to participate in this research project?
"That is correct, the online information regarding this clinical trial indicates that it is still recruiting patients. This particular study was first posted on November 21st, 2021 and the most recent update was February 7th, 2022. A total of 24 people are needed to enroll between 1 site."
Answered by AI
Are we able to sign up for this experiment at the moment?
"Yes, this information is accurate. The clinical trial in question was posted on November 21st, 2021 and updated as recently as February 7th, 2022."
Answered by AI
Would I be a good candidate for this clinical trial?
"This study is looking for 24 individuals that have essential tremor and are aged between 18-75. The applicants must meet the following prerequisites: Written and Signed Informed Consent, Age 18 to 75 years old, 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)., Subject has a diagnosis of essential tremor, as defined by all the following"
Answered by AI
What is the status of ES-481's application for FDA approval?
"ES-481's safety is estimated to be a 2. This is due to it being in Phase 2 of clinical trials, where there is some evidence for safety but not efficacy."
Answered by AI
Who else is applying?
What state do they live in?
California
North Carolina
Virginia
Other
How old are they?
18 - 65
What site did they apply to?
Clinique Neuro-Levis
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger