Research Studies
Posted on July 6, 2020

Study Description:

The KINETIC Trial is a clinical research study evaluating the safety and effectiveness of an investigational drug in individuals diagnosed with essential tremor. Researchers are evaluating if the investigational drug is effective in reducing tremors.

The study comprises three periods: screening, treatment, and follow-up. Participation in the study will last approximately 71 days and will consist of seven study visits.

Study Details:

Phase: 2
Type: Double-blind, placebo-controlled
Interventions: investigational drug, placebo
Gender: Male, female
Minimum age: 18 years
Maximum age: 80 years
Enrollment goal: Approximately 60 patients
Compensation range: Speak with study site for more details
Participation length: Approximately 71 days

Study Purpose:

The overall goal of the study is to evaluate the safety and effectiveness of the investigational drug in adults with essential tremor.

Eligibility Criteria:

Key inclusion criteria:*

  • You should discuss with your prescribing physician before discontinuing any medications you are currently taking
    • Medications taken for the treatment of essential tremor that were discontinued prior to receiving the investigational medication may be resumed following Day 29 of the study

Key exclusion criteria:*

  • Participant has had an injury to the nervous system that occurred within three months before the tremors began
  • Participant has had a previous procedure for the treatment of essential tremor
  • Participant has historical or clinical evidence of tremor that occurs because of psychological or psychiatric causes, including but not limited to eating disorder or major depressive disorder
  • Participant has had exposure to another investigational drug or device within 30 days prior to the Day 1 visit
  • Female participant has a positive pregnancy test or a confirmed pregnancy at time of study
  • Participant is unwilling or unable to follow the study instructions

*There are additional eligibility requirements which the study doctor can explain to you.

To learn more or prescreen for the KINETIC Trial please visit KineticETtrial.com.

MRC-324-00143
IETF Trial Listing_324-ETD-201_06032020_V1.0
© 2020 Sage Therapeutics, Inc. All rights reserved. KINETIC Trial is a trademark of Sage Therapeutics, Inc.
Research Studies

Yale University – New Haven, Connecticut

What causes essential tremor is currently a question with no known answer. Brain donations (also called postmortem examination or autopsy) are the only way to find the answers to this question. With these answers, better treatments can be developed and a cure can be found.

Medical researchers at Yale University, with the help of the IETF, maintain a centralized brain bank to serve the ET community. This will enable doctors to begin to actively study what happens in the brains of people with ET. Unfortunately, there is a severe shortage of brain tissue donations from people who had ET during life.

Eligible donors will have been diagnosed with essential tremor by a physician, they would not have any other neurological diagnoses (eg. Dystonia, torticollis, Parkinson’s disease), would be ages 70 and older, and had not had Deep Brain Stimulation surgery or any other surgical intervention to treat their tremor.

If you are interested in helping find the causes of ET and want to leave a medical legacy for future generations, please call 203.785.5301 or email tremor@yale.edu, and you will be sent an information packet on brain donation. Or for more information, visit www.essentialtremor.us.

Brain Donor Project

The Brain Donor Project is a non-profit that supports the brain banks of the National Institutes of Health (NIH), the NeuroBioBank, to increase the supply of donated brain tissue for scientific research. There is no cost to the family to donate a brain to a NeuroBioBank site, nor to receive a copy of the donor’s neuropathology report if requested. No age restrictions and very few limitations on eligibility are in place, but it is highly recommended to register in advance. Learn more.

The Brain Observatory – San Diego, California

The Brain Observatory’s brain bank in San Diego, California is now accepting brain donations from patients who have been diagnosed with Essential Tremor (ET). The effort is part of the institute’s Digital Brain Library project, a web-accessible digital archive of neurological data that will be open to worldwide collaboration. Potential brain donors may also participate in active ET research. By combining modern neuroimaging techniques and detailed behavioral testing with the eventual examination of the brain, researchers aim at obtaining a new and more comprehensive picture of ET.

Note: The program is currently enrolling only residents of San Diego county; however, potential participants from other areas will be signed into a registry that may be the basis for future larger studies.

Please contact Mrs. Ruth Klaming for more information about brain donation or research participation. For more details on the Digital Brain Library, visit their website.

Research Studies

Dr. Elan Louis and colleagues at Yale University in New Haven, Connecticut have undertaken a new research initiative. The objective of this research is to use new advanced imaging methods to learn what is happening in the brains of people with ET. They are calling on the assistance of the ET community to help them complete this groundbreaking, NIH-funded research.

Interested candidates would comply with the following criteria:

  1. You have been diagnosed by a doctor as having ET (rather than dystonia, for example).
  2. You are at least 65 years old.
  3. You did NOT have brain surgery for ET.
  4. You do NOT have any metals in your body (pacemakers, stents, prosthesis, etc.) – this would contraindicate performing an MRI scan of your brain.
  5. You do NOT receive treatment with primidone or topiramate.
  6. You are willing to have two interviews (one now and one in 3 years) with us at Yale, or at your home. During each interview, after some questionnaires, an MRI scan of the brain will be performed. Each interview/scan will last approximately 3 hours.
  7. You are willing to consider becoming a brain donor in the future. We would discuss this further with you.
  8. We are also recruiting people who do not have essential tremor as control participants.

Participants will be compensated $125 after each interview (total compensation after completing the two interviews: $250).

If you are interested, send an email to tremor@yale.edu or call 203.785.5754.

Research Studies

Dr. Elan Louis at Yale University and Dr. Lorraine Clark at Columbia University They are calling on the assistance of the ET community to help them complete this groundbreaking family research study, which at the moment is the largest NIH-funded project of its kind. This is a nationwide study, and the researchers will travel to meet with qualified participants and there are no costs to participate. The help of the ET community is vital.

Eligible candidates would comply with the following criteria:

  • You have been diagnosed by a doctor as having ET (rather than dystonia or Parkinson’s Disease, for example).
  • Your tremor started by the time you were 50 years old.
  • You have at least two living relatives who have been diagnosed as having ET by a doctor without any accompanying dystonia or Parkinson’s disease.
  • You have at least two relatives who do not have ET.
  • You think you and your family members would be willing to donate a blood sample, answer some questionnaires and undergo a videotaped neurological exam.

If you are interested, call 203.785.5719 or email tremorgenetics@yale.edu.

Research Studies

Mount Sinai School of Medicine is conducting an essential tremor research trail. This study is only open to those living in the New York City area. This research trial will study persons who:

  • have essential tremor
  • have troublesome hand tremor
  • have tremor in both hands
  • do not have liver insufficiency

The purpose of this research study is to find out whether perampanel, a medication marketed for the treatment of seizures, reduces hand tremor in persons with essential tremor. Participants will have tremor observed and video-taped and answer questionnaires so that investigators can find out whether perampanel reduces tremor. During the study, perampanel is taken for 14 weeks, and a placebo for 14 weeks. Total participation will last up to 40 weeks. There are a total of 6 visits, and participants will be compensated for each visit.

To learn more about “A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel for Essential Tremor” contact the Principal Investigator:

Mindy Lopez
The Robert and John M. Benheim Parkinson’s and Movement Disorders Center
New York, NY
212-241-9038
mindy.lopez1@mssm.edu

Winona Tse, MD
Department of Neurology
Icahn School of Medicine at Mount Sinai
5 East 98th St., New York
212-241-5607
winona.tse@mssm.edu

Joan Bratton
212-241-0279 or joan.bratton@mssm.edu

Research Studies

Dr. Elan Louis at Yale University is spearheading an important research initiative. This National Institute of Health (NIH) funded study aims to better understand the lifestyle habits of essential tremor (ET) families. We are calling on the assistance of the ET community and their families to help us with this new research. This is a national study.

The research team is interested in contacting and meeting with the parents, brothers, sisters, and children of people with ET.

An eligible participant must:

  • Not have ET (You didn’t misread this, we are interested in unaffected people)
  • Be at least 40 years old
  • Not have Parkinson’s disease or dystonia
  • Be willing to undergo a 2-hour health evaluation in your home. This will include, questionnaires, a formal assessment of your health and diet, a videotaped neurological exam, and a blood draw.

This is a nationwide study, in which we will travel to meet with you individually at a date and time convenient for you. There are no costs associated with your participation; in fact, you will be compensated for your time.

If you are interested or have any questions, please call (203) 785-2086 or e-mail rulet@yale.edu.

Research Studies

The essential tremor research team at Columbia University, headed by Dr. Sheng-Han Kuo, is looking for people in the New York City area with essential tremor, to study their brain activity using an electroencephalogram (EEG).

EEG is a routine clinical procedure to study brain activity and could be used to study essential tremor. One of the most important questions for essential tremor is: from which region of the brain does the tremor originate? To try and answer this question, researchers will place EEG leads on the scalp of study participants, to study their brain activity. Researchers will study activity across the whole brain with the hope of identifying the source of the abnormal brain activity that causes tremor. This study aims to help researchers better understand the area of the brain responsible for essential tremor, which will, in turn, help researchers find more effective ways to treat it.

Study Details

  • EEG is a non-invasive procedure.
  • You will need to travel to Columbia University Medical Center for this study, but reimbursement will be provided for travel expenses.
  • The study will last for approximately 2 hours.
  • There is no blood draw involved.

Inclusion Criteria
In this study, researchers are looking for people who have had a diagnosis of essential tremor for more than 3 years.

Contact Information
If you are interested in this study or have questions, please contact Dr. Shi-Bing Wong or call 212-342-3753.

Research Studies

Researcher’s at McGill University in Montreal, Quebec, Canada are conducting the largest genetics study of essential tremor patients ever. They require 10,000 participants affected by essential tremor. This is a global study and there is no travel involved.

Inclusion Criteria:

  • This study is open to anyone who has essential tremor, even if you have not been officially diagnosed by a physician.
  • Participants must be at least 16 years old.
  • It is okay if you are currently on medication for your essential tremor.

If selected, you will be provided with several necessary documents: a consent form, a genealogy form, and a writing test. Upon completion, these documents can be returned to the researchers via email or postal mail. These documents will be examined by a specialist to determine if you qualify for the next stage of the study.

If selected, you will receive all the necessary informational materials and a prescription to have your blood drawn for testing. Packaging and shipping for sending your sample back to the researchers will also be provided.

Your help is needed if we are to understand the cause of essential tremor. If you have questions about this study, please email the researchers directly.

Research Studies

Researchers at Brigham Young University (BYU) are looking for people with essential tremor to participate in a research study. This study, headed by Steven Charles, Ph.D., is aimed at better understanding the effect of sensory stimulation on tremor.

Study Details

  • The experiment is non-invasive.
  • It consists of a single session lasting approximately 2 hours.
  • It is performed in a laboratory on the BYU campus or, alternatively, in your home or the home of an acquaintance.
  • Participants will receive $50 in compensation.

Participant Criteria

  • 18 years or older
  • Diagnosed with essential tremor by a neurologist.
  • Willing to travel to the BYU campus in Provo, Utah, or live within a 2-hour drive of Provo.

If you are interested in participating in or have questions regarding this study, please contact Joseph Bonham or call 928-243-8170.

Research Studies

Dr. Elan Louis at Yale University is leading an important research initiative. A regional study is being funded by the National Institutes of Health (NIH) and is looking for participants.

Risk Factors Underlying Essential Tremor (RULET): This study seeks to understand the environmental factors that lead to Essential Tremor (ET) and Parkinson’s Disease (PD).

  • Eligible participants must meet ALL of the following criteria:
    1. Have ET or both ET & PD
    2. Live in the tri-state area (Connecticut, New York, or New Jersey)
    3. Be at least 40 years old
    4. Not have dystonia
    5. Be willing to undergo a two-hour health evaluation in your home. This will include questionnaires, a formal assessment of your health and diet, a videotaped neurological exam, and a blood draw
  • All participants will receive $40 compensation.
  • If interested, email RULET@yale.edu or call (203) 785-7939 for more information.

Researchers will travel to meet with qualified participants meaning there are no costs associated with participation. We need the help of the ET community to continue this important research.