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NT 201 for Essential Tremor
Study Summary
This trial is testing whether botulinum toxin is more effective than a placebo for treating essential tremor in one arm. Participants will be randomly assigned to treatment groups, and neither they nor the staff will know who is in which group. All participants will then receive botulinum toxin treatment.
- Essential Tremor
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 256 Patients • NCT02270736Trial Design
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- You have neurological symptoms like uncontrolled movements or difficulty with coordination that could affect the diagnosis or evaluation of your condition.Your tremors vary too much from day to day, making it difficult to accurately measure your progress in the study.A person has a score of ≥2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) if an independent TETRAS expert confirms this by means of video assessment.You have tremors that are not essential tremors.
- Group 1: NT 201 (IncobotulinumtoxinA, Xeomin)
- Group 2: Placebo
- 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
Have any other experiments been conducted regarding the effects of NT 201?
"61 clinical trials for NT 201 are currently in operation, with 20 of those being Phase 3 studies. As the majority of these experiments occur at Farmington Hills, Michigan, there are over 750 other medical sites trialing this treatment too."
Has NT 201 gained regulatory clearance for therapeutic use?
"Our evaluation of NT 201's safety is a 2 on the scale, as clinical trials to date have only shown limited evidence that it can be tolerated. There are no data yet proving its efficacy."
Can you provide an estimate of the total number of individuals involved in this medical experiment?
"This trial requires 75 qualified individuals to partake in the study. Possible locations include Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457 located in Las Vegas and London Health Sciences Centre's Merz Investigational Site #0010087 situated in London, Ontario."
Is the trial being conducted in multiple locations within this municipality?
"Patients in the clinical trial will be enrolled at Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457 located in Las Vegas Nevada; London Health Sciences Centre, Merz Investigative Site #0010087 based out of London Ontario; and Houston Methodist Neurological Institute, Merz Investigational Site #0010226 situated within Houston Texas. Additionally, 10 other sites are participating in this medical study."
Is enrollment into this medical experiment still available?
"Affirmative, the information posted on clinicaltrials.gov states that this trial is currently recruiting candidates. It was first published on February 24th 2021 and last modified on November 17th 2022 with a goal of enrolling 75 patients from 10 different medical centres."
In what medical conditions does NT 201 offer therapeutic relief?
"NT 201 is a common treatment for urinary incontinence, as well as conditions like spinal cord damage and overactive bladder syndrome (OABs)."
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