At home, it’s easier to manage essential tremor.
We designed a study to meet you there.
Consider an essential tremor research study where you can participate from the comfort of your home.
Living With Essential Tremor
You’ve been doing your best to manage your essential tremor since your diagnosis. However, you may have noticed that things you consider simple tasks are getting more difficult. You’ve developed a routine and workarounds at home, but the uncertainties of going out make you uncomfortable at times. And although you appreciate the help from loved ones and others, it’s embarrassing and frustrating when they have to step in to help. You’ve tried medications, but they haven’t really provided you enough relief from your tremor.
About the Essential3 Study
The Essential3 study is an at-home research study evaluating an investigational drug, in accordance with FDA requirements, to see if it may improve your ability to complete everyday tasks, such as eating, drinking and dressing.
In participating, you may receive the active investigational drug or the placebo. You will have the opportunity to take the active investigational drug for up to a total of 1 year if you wish to continue beyond 14 weeks.
The Essential3 study has been designed so that you may participate from the comfort of your own home. There is no travel or trips to the doctor’s office required. The study encompasses the following:
- Home health visits with a study nurse
- Telehealth visits with the study doctor via your smartphone or tablet
- Phone calls with study staff regarding any questions or concerns
- Use of digital apps for the completion of questionnaires
How Do I Qualify?
You may be eligible for the Essential3 study if you:
- Are 18 to 85 years old
- Have been diagnosed with essential tremor by a physician and had symptoms for at least 3 years
- Experience tremor in both hands
- Have not had surgery for your essential tremor
- Are not currently taking the medication Primidone (Mysoline)
- The Essential3 study requires that participants have not taken Primidone for at least 2 weeks before starting the study. Please consult your doctor before you make any changes to your medication.
Depending on the other medication you are currently taking for essential tremor, you may be able to continue that medication.
This is not a full list of study entry criteria. The study staff can discuss with you the specific medications you are taking as well as any additional criteria to participate.
Patient Pathway
- Complete the prescreener questionnaire on the website to see if you prequalify.
- Receive a phone call from the Study Coordinating Center to answer additional questions, initiate medical history release and schedule your screening visit.
- Telehealth visit to review the study informed consent form.
- A nurse will visit your home to help you complete your screening visit and complete enrollment paperwork, pending verification for study participation.
- Study visits throughout your participation will take place in your home. A study nurse will be with you at some of these visits to assist you with study procedures and drug administration.
- The study app will be used for the telehealth visits and ongoing diary entries in between study visits.
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Why Take Part?
If you qualify and decide to participate, you will receive:
- All study-related care at no cost
- Close monitoring by an experienced doctor and study staff who understand essential tremor
- The opportunity to advance medical knowledge and potentially help others with essential tremor
Your safety is the highest priority while participating. If you have questions or concerns at any point throughout the research study, you will have a direct contact who you can engage for support at any time.
Your participation is voluntary. You are free to withdraw at any time, and for any reason. Your privacy will be maintained throughout the study.
To learn more, download the Essential3 study flyers here:
Patient Flyer PDF
Caregiver Flyer PDF
Frequently Asked Questions
This section will help answer some important questions you may have.
About the Essential3 Study
The Essential3 study is a Phase 3 clinical research study of an investigational drug being evaluated for its safety and efficacy in the treatment of essential tremor in adults. In previous Phase 1 and 2 studies, the investigational drug was shown to be both safe and effective in its treatment of essential tremor. Once a Phase 3 study is completed, FDA approval can be requested.
The investigational drug is being studied to evaluate if it blocks signals to the brain that may cause symptoms of essential tremor and improve your ability to complete everyday tasks, such as eating, drinking, and dressing.
The investigational drug is a tablet taken orally. Participants will take it once a day at the same time each morning.
A decentralized study has no fixed study site you are required to visit. Instead, you are able to participate in the Essential3 study from the comfort of your own home. This means:
- Home health visits with a study nurse who will perform study procedures and assessments
- Telehealth visits with the study doctor to review your symptoms, medications, and questionnaire responses—conducted via your smartphone or tablet
- Phone calls with study staff, who are there to answer any questions or concerns you may have
- Use of digital apps that will allow you to complete questionnaires throughout the study
The study lasts 14 weeks. There is an opportunity to continue taking the investigational drug for up to a total of 1 year (or up to an additional ~9 months) if you wish. All visits will take place via telehealth or in your home. You will not need to travel to a study site.
Before you agree to participate, the study staff will review all aspects of the study with you, including if you are eligible to participate, and will review the required study assessments with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the study’s purpose, assessments, procedures, potential benefits and risks, precautions, whom to contact with questions about the study, and how to report a side effect. You will have the opportunity to ask questions and decide if taking part is right for you.
The study staff will provide you with more information about whether you will be able to continue your other medications. Please do not make any changes to your medications without first talking to your physician and the study staff.
A placebo looks like the investigational drug but does not contain any active investigational drug.
If you are eligible to participate, the study staff can provide more information and answer your questions.
Privacy, Stopping Participation, Costs, and Permission
The study staff respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.
Your participation in the research study is entirely voluntary and you may withdraw at any time. If you decide to withdraw early, you will be asked to notify the study staff before doing so, and have a final home health visit as soon as possible to return any unused investigational drug and receive physical and symptom assessments. You will also be asked to attend a safety follow-up visit via telehealth 14 days after your last dose to evaluate your overall health and symptoms.
There is no charge for taking part. All assessments and investigational drug related to the research study are provided at no charge.
Yes, you will receive reimbursement for each home health visit and telehealth visit completed.
Your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your regular doctor to discuss your participation before you begin and keep your doctor up to date about your participation.
About Research Studies
A clinical research study, also known as a clinical trial, is a scientific study that can evaluate the way an investigational drug works in the body, including assessing its safety, effectiveness, or the way the body processes it. A research study may show that the investigational drug is better than, as good as, or worse than the standard treatment or a placebo (which looks like the investigational drug but contains no active ingredient). Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.
In order to ensure that a research study is ethical, and that participants’ rights are protected, Institutional Review Boards review and approve study protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, confirm that the study protocol procedures and research study requirements and regulations are being followed throughout the study.
Only participants who meet all required eligibility criteria and are willing to participate in all study-related assessments, as described in the Informed Consent Form, may take part in a research study. The study staff will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the study. You may also be asked to provide information from your medical records to help the study staff determine whether or not you may be eligible.
An investigational drug is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration) for prescription use that is utilized to conduct clinical research studies. An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it.