CLINICAL TRIAL

NTX-001 for Peripheral Nerve Injuries

Waitlist Available · 18 - 65 · All Sexes · Baltimore, MD

This study is evaluating whether a fusion of a polymer to a nerve may help promote nerve regeneration.

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About the trial for Peripheral Nerve Injuries

Treatment Groups

This trial involves 2 different treatments. NTX-001 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
NTX-001
DRUG
Experimental Group 2
NTX-001
DRUG

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Involves injury or dysfunction to the motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve, usually caused by compression or stretch of the nerve show original
A person sustained a complete peripheral nerve injury from upper extremity trauma that happened within 48 hours of the injury. show original
Involves a nerve that contains both sensory and motor fibers. show original
Ages 18-60
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether NTX-001 will improve 1 primary outcome and 6 secondary outcomes in patients with Peripheral Nerve Injuries. Measurement will happen over the course of Up to 2 years.

Grip Strength
UP TO 2 YEARS
Grip strength is assessed using a hand-held Jamar dynamometer.
Pain Score
UP TO 2 YEARS
Self reported outcomes using the Brief Pain Inventory.
Range of Motion
UP TO 2 YEARS
ROM will be measured using a standard goniometer.
Motor Function
UP TO 2 YEARS
Motor function will be evaluated using the British Medical Research Council motor grading scale. Motor is evaluated on a scale of M0 and M5, where M5 is the highest score and M0 is the lowest.
Sensory Function
UP TO 2 YEARS
Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.
Complications or problems that occur with in the first 30 days.
UP TO 2 YEARS
Complications or problems include surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes peripheral nerve injuries?

Injury to peripheral nerves is commonly caused in the course of performing invasive or non-invasive procedures, or by repetitive work. Prevention is mostly based on the avoidance of these hazards.

Anonymous Patient Answer

What are common treatments for peripheral nerve injuries?

There are no common treatments for peripheral nerve injuries. Peripheral nerve injuries require a wide variety of treatments that are individualized based on the nature and location of the injury and on the patient's comorbidities and needs. The goal of treatment depends on the severity and degree of nerve compression and/or injury and is chosen by the treating physician. While there are few high-quality trials, the use of surgical techniques, nerve-sparing surgical techniques, and endoscopic nerve-sparing techniques can preserve function and reduce recovery time and risk of nerve morbidity. TENS is effective as an adjunctive therapy to other treatments before a muscle-relaxation technique in cases of persistent pain.

Anonymous Patient Answer

What are the signs of peripheral nerve injuries?

The authors present a list of pertinent signs of nerve injuries and their importance to recognize and record in patients. They also suggest the use of a clinical prediction model that may help guide preoperative management in patients presenting with peripheral nerve injuries.

Anonymous Patient Answer

What is peripheral nerve injuries?

Peripheral nerve injuries are a group of diseases that can cause numbness, tingling, paralysis or even amputation. PNI are usually due to traumatic injury in which sharp objects or bones and joints may be fractured resulting in nerve damage as well as chronic or repetitive stress. The most common type of peripheral nerve damage is entrapment where a nerve becomes trapped for a prolonged period of time between a non-returning tissue that is strong enough to prevent the nerve from escaping such as bone or muscle, which can be further exacerbated by improper surgical technique, such as neurotmesis. Peripheral nerve injuries may also be caused by physical force such as a fracture.

Anonymous Patient Answer

How many people get peripheral nerve injuries a year in the United States?

The data collected in this article do not provide a estimate of annual numbers of peripheral nerve injuries. There is a need to standardize the data collection methodology and tools. An objective, standardized system to survey peripheral nerve injuries is crucial to provide a complete estimate of the numbers of individuals affected by nerve injuries in the United States. With the availability of information of patient satisfaction, treatment failures and nerve injuries, information regarding the quality of care provided to patients with peripheral nerve injuries and information about patient satisfaction will be useful tools to measure effectiveness.

Anonymous Patient Answer

Can peripheral nerve injuries be cured?

A high dose of intravenous glutamine, 2.5% on a day-to-day basis, does accelerate the healing process of nerve injuries and improves recovery of muscular and nerve functions.

Anonymous Patient Answer

Who should consider clinical trials for peripheral nerve injuries?

Patients who are well and whose injuries are isolated to their superficial nerves are excellent candidates for clinical trial. Patients who sustained more severe injuries or were part of a larger mass lesion and who have additional neurologic abnormalities are candidates for clinical trial. Patients with other injuries that do not alter outcomes and who can achieve better functional outcomes may be candidates for clinical trial.

Anonymous Patient Answer

Is ntx-001 safe for people?

Ntx-001 is a well-tolerated, simple to use, and very inexpensive analgesic. It does not appear to be associated with an increased risk of adverse effects, particularly fractures. It is an effective analgesic when used in people with a history of or ongoing lower spine osteoporotic fractures including in the setting of other chronic pain syndromes.

Anonymous Patient Answer

Have there been other clinical trials involving ntx-001?

Ntx-001 is being investigated as a medication for the treatment of several central nervous system diseases. Ntx-001 is currently in clinical trial in patients with Parkinson's disease and multiple sclerosis. The drug is also in clinical trial in patients with chronic pain. Ntx-001 was granted a conditional marketing authorisation pending the results of two ongoing Phase III trials. There were no other published clinical trials in which Ntx-001 has been investigated. Based on present knowledge and research, the authors did not anticipate that Ntx-001 might be a candidate for use in any of the clinical indications mentioned above.

Anonymous Patient Answer

What are the latest developments in ntx-001 for therapeutic use?

Ntx-001 has shown promise in preliminary experiments of the treatment of peripheral neuropathies. Clinical trials are planned with further details to be discussed during the next International Meeting on Nerve Damage Treatment (IFENNT 2014 = ISNTNCT00958409) in Vancouver, Canada.

Anonymous Patient Answer

What does ntx-001 usually treat?

In this small retrospective study, the clinical presentation of Ntx-001 was consistent with that of other NTF2-related neuropathies. In the current situation, Ntx-001 may be considered as an alternative to costly and lengthy immunosuppression.

Anonymous Patient Answer

What is the primary cause of peripheral nerve injuries?

The primary cause of peripheral nerve injuries was found to be traction during the operative procedure rather than laceration at the site of injury. Wound complications, which included infection, were more critical than the type of nerve injury in determining the long-term function loss.

Anonymous Patient Answer
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