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NTX-001 for Facial Palsy
Study Summary
This trial is testing an investigational product called NTX-001 for safety and effectiveness in repairing nerve damage. Researchers will compare NTX-001 to the current standard of care to see if it leads to faster nerve function recovery.
- Facial Palsy
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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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- You have Bell's palsy, but if you show signs of getting better on your own within a year, you won't be included in the study.You need surgery to fix the facial nerve inside your head.You need a specific type of surgery that involves using someone else's tissue, except if it's for repairing the main facial nerve.You have facial paralysis that needs treatment or repair due to a condition or procedure that may cause or has caused paralysis.Your facial muscles are severely weakened and unlikely to recover within 6 weeks.You have a history of significant nerve problems or neurological conditions that are not related to the condition being studied. You also have an allergy to polyethylene glycol (PEG) or human-grade silicone.
- 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
Are there any significant risks associated with taking NTX-001?
"Considering that there is evidence of NTX-001's safety but not its effectiveness, we have rated it a 2 on the 1 to 3 scale."
Am I qualified to participate in this research endeavor?
"This current trial is recruiting a cohort of 36 participants aged 16 to 80 with facial paresis. Furthermore, they must have medical evidence that an intervention or condition has caused paralysis requiring nerve repair."
How many participants have enrolled to be a part of this clinical experiment?
"Indeed, the information on clinicaltrials.gov confirms that this medical trial is actively recruiting participants. Having been first posted 12th July 2022 and last updated 28th September 2022, 36 patients need to be enrolled from 4 different sites."
Are there a myriad of research facilities conducting this experiment across the United States?
"Patients can find this clinical trial at the University of Indiana in Indianapolis, Washington University in Saint Louis, Duke University Medical Center in Durham. There are also 4 other locations participating."
Are there any opportunities right now to join this research project?
"Affirmative. On clinicaltrials.gov, we can see that this research is presently recruiting subjects. First uploaded on July 12th 2022 and revised September 28th 2022, the study seeks to enrol 36 individuals at four distinct medical centres."
Does the protocol for this clinical trial permit people below 45 years of age to participate?
"This medical trial requires applicants to be aged between 16 and 80. There are 51 trials suitable for those younger than 18, while 69 studies cater towards elderly patients above 65 years of age."
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What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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