Essential tremor makes doing simple things harder
Learn about a clinical research study for an oral study drug being evaluated for the treatment of essential tremor in adults.
Living With Essential Tremor
Having essential tremor can be extremely frustrating. Simple tasks like getting dressed, writing, or holding a cup start to feel monumental. You’ve managed over the last several years, but your symptoms seem to be getting worse, especially when you’re tired or stressed. You may have tried some medications, but they just haven’t given you enough relief from your tremor.
About the Essential1 Study
The Essential1 study is evaluating an oral study drug to see if it may reduce symptoms of essential tremor. If you have symptoms of essential tremor, with or without medication, this study may be an option for you.
How Do I Qualify?
You may be eligible for the Essential1 study if you:*
- Are 18 years or older
- Have symptoms of essential tremor for at least 3 years
- Experience tremor in both hands
- Have not had surgery for your essential tremor
Depending on the medication you are currently taking for essential tremor, you may be able to continue that medication.
*The study staff can discuss with you the specific medications you are taking as well as any additional criteria to participate.
Why Take Part?
If you qualify and decide to participate, you will receive:
- The study drug and all study-related care at no cost
- Close monitoring by an experienced study doctor and staff who understand essential tremor
- The opportunity to advance medical knowledge and potentially help others with essential tremor
At the end of the Study Treatment Period, there is an optional Extension Study in which all participants will receive the oral study drug. The study staff can provide more details.
Your safety is the highest priority while participating. If you have questions or concerns at any point throughout the study, a study staff member is available. The study staff can also tell you about their COVID-19 safety protocols.
Your participation is voluntary, and you are free to withdraw at any time, for any reason. Your privacy will be maintained throughout the study.
This section will help answer some important questions you may have.
About the Essential1 Study
The Essential1 study is a clinical research study for an oral study drug being evaluated for the treatment of essential tremor in adults.
The study drug is being studied to evaluate if it blocks signals in the brain that may cause symptoms of essential tremor.
The study lasts up to 14 weeks and includes up to 7 visits at the study doctor’s office and 4 telephone check-ins. There is also an optional extension study, during which all participants receive the oral study drug. The extension study lasts up to 21 weeks and includes up to 6 visits at the study doctor’s office and 4 telephone check-ins.
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, benefits, 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 or the study staff.
A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
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 return to the clinic at least once to complete a final visit and return any unused study drug. You may also be asked to continue attending study visits without taking the study drug, but you will not be required to do so.
There is no charge for taking part. All assessments and study drug related to the research study are provided at no charge.
You will not be paid for taking part in the study. The study staff can inform you about reimbursement for expenses incurred to attend study visits, if you are eligible.
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 progress.
About Research Studies
A clinical research study, also known as a trial, is a scientific study that can evaluate the way a study drug works in the body, including assessing its safety, effectiveness, or the way the body processes it. A research study may show that the study drug is better than, as good as, or worse than the standard treatment or a placebo (which looks like the study 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 (IRBs) or Ethics Committees (ECs) 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, visit the study sites to confirm that the study protocol procedures and research study requirements and regulations are being followed throughout the study. Health authorities may also inspect the study sites to ensure the safety and rights of participants in a research study and the integrity of the research study objectives.
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 at the clinic you select 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.
A study drug is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration or Health Canada) for prescription use that is utilized to conduct clinical research studies.