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NTX-001 for Peripheral Nerve Injury
Study Summary
This trial is testing a new product that may help people with severed nerves.
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
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Who is running the clinical trial?
Media Library
- I have a health condition that prevents me from having surgery right now.My nerve injury can be fixed with direct repair without much tension.I have not taken treatments affecting my nerves or blood vessels.My surgery is scheduled within 2 days of my injury.My nerve injury is severe, affecting the internal structure.I have a nerve injury that cannot be fixed without causing too much tension.I have a confirmed single cut nerve injury from surgery.I am between 16 and 80 years old.My nerve injury involves blood vessel damage that can't be fixed to restore proper blood flow.
- Group 1: NTX-001
- Group 2: Standard of Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this clinical trial accepting patients of all ages?
"This clinical trial is only open to applicants aged 16 to 80. There are 126 other trials available for people under 18 and 624 for those over 65."
Are there any medical conditions which would make a person ineligible for this clinical trial?
"This study is only open to those who have experienced peripheral nerve damage and are between 16-80 years old. The team conducting the research is looking for approximately 40 participants."
Are there many clinics running this study in the city?
"11 locations are currently running this clinical trial, these include University Medical Center in New Orleans, University of Chicago in Chicago and Curtis National Hand Center in Baltimore."
Are there any available slots left for potential participants?
"Indeed, the trial is still ongoing and recruiting patients from 11 sites. So far, 40 individuals have been enrolled in the study since it was first posted on September 25th, 2020."
Has NTX-001 met the safety and efficacy standards set by the FDA?
"Because NTX-001 is only in Phase 2 trials, meaning that there is data supporting safety but not efficacy, our team at Power rates the safety a 2."
What are the goals that this experiment is looking to achieve?
"The primary objective of this clinical trial is to assess the efficacy of the treatment intervention in terms of the Michigan Hand Questionnaire Total Score (MHQ). Secondary objectives include measuring Patient Global Impression of Change (PGIC), Numeric Pain Rating Scale (NPRS), and Modified British Medical Research Council (MMRC) sensory grading."
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