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SAGE-324 for Essential Tremor
Study Summary
This trial is testing different doses of SAGE-324 to see how it affects upper extremity tremor in people with essential tremors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Who is running the clinical trial?
Media Library
- My arm strength score is 6 or more.I am willing to stop my essential thrombocythemia (ET) treatment before starting the trial medication.I have been using the Cala Trio bracelet for my ET for at least two weeks.I am currently taking propranolol for a condition that is not essential tremor.I do not have other major nerve system symptoms like uncontrolled movements or balance issues.I haven't taken any new tremor-causing drugs or experienced alcohol withdrawal in the last 14 days.My upper limb tremor score is 12 or more.You have a condition that causes increased shaking or trembling in your body.I may have tremors in parts of my body like my head, voice, or legs.My dominant arm's function scores at least 6 on a specific test.You have a history of drug or alcohol abuse, or have tested positive for drugs at the screening.I am willing to stop my essential tremor medications except propranolol before starting the trial.I have undergone a procedure like deep brain stimulation for essential tremor.I have received botulinum toxin for essential tremor within the last 6 months.I agree to limit my alcohol intake and keep my nicotine use the same as before the study.I have been diagnosed with Essential Tremor in my arms for at least 3 years.I have been on a stable dose of propranolol for ET treatment for at least 3 months.I experienced a nerve injury or trauma within 3 months before my tremor started.I can perform most daily activities by myself.I have been diagnosed with Essential Tremor in my arms for over 3 years, with no other major neurological issues.I have tremors due to a functional neurological condition.I have had a shaking in both my hands when I move them for over 3 years.My upper limb tremor score is 12 or more.
- Group 1: SAGE-324 30 mg
- Group 2: SAGE-324 Matched Placebo
- Group 3: SAGE-324 60 mg
- Group 4: SAGE-324 15 mg
- 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
How many geographic sites has this clinical trial been instituted in?
"Presently, this research project is attempting to secure patients from 21 medical centres. Cincinnati, Dayton and Las Vegas are among the most prominent locations; however there are 18 other sites close by that may be convenient for potential participants."
To what extent is the population being scrutinized in this research study?
"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial, which was initially uploaded on January 24th 2022, is currently recruiting patients. 160 individuals across 21 sites need to be enrolled in the study."
Has the federal government given clearance to SAGE-324?
"The safety rating of SAGE-324 is a 2 since this Phase 2 trial has accumulated evidence to attest its security but not sufficient proof regarding efficacy yet."
Who meets the criteria for inclusion in this experiment?
"This medical study is searching for 160 participants aged 18 to 80 with familial tremor. In order to be accepted, potential volunteers must have a combined TETRAS Performance Subscale Item 4 score of 12 at pre-screening and Day 1 before the dose, as well as 6 in their total dominant upper limb score from both checkpoints. Additionally, patients must discontinue any medications taken for ET treatment 14 days or longer (depending on half life) prior to receiving IP and they cannot show signs of other neurological conditions like dystonia, parkinsonism, etc."
Is this research project currently seeking participants?
"As per the latest update on clinicaltrials.gov, this medical study is still enrolling volunteers. The trial was first posted in late January of 2022 and has been amended as recently as September 7th of the same year."
Does this trial accept applicants of advanced age?
"To be eligible for this medical trial, patients must have their 18th birthdays but not yet celebrated their 80th. Separate trials are available to those younger than 18 and older than 65 years of age; the latter requires 50 participants."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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