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N/A

PEG Fusion for Peripheral Nerve Injury

Phase 2

Recruiting

Led By Jaimie Shores, MD

Research Sponsored by Major Extremity Trauma Research Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-80

Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist

Must not have

Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN)

Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a reagent called PEG fusion is safe for promoting nerve regeneration in humans. The trial will establish safety data and examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function.

Who is the study for?

This trial is for adults aged 18-80 with acute upper extremity peripheral nerve injuries, specifically to the axillary, radial, median, ulnar, or musculocutaneous nerves. Candidates must present within 48 hours of injury and have both sensory and motor function impairment. Exclusions include brachial plexus injuries, purely sensory nerve damage beyond the wrist, previous neurological disorders or trauma, severe psychiatric conditions that could affect follow-up compliance or pose a self-harm risk.

What is being tested?

The study tests PEG fusion's safety in promoting nerve regeneration after an acute injury. Participants will undergo primary repair or reconstruction using PEG fusion to evaluate its effect on restoring sensory and motor functions. This Phase 2a trial aims to provide safety data and preliminary evidence for a larger efficacy trial.

What are the potential side effects?

Specific side effects are not listed but participants with known allergies to polyethylene glycol (PEG) are excluded from the trial suggesting potential allergic reactions as a concern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have nerve damage in my arm between my shoulder and wrist.

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I have a recent complete nerve injury in my arm from an accident.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My injury affects a nerve in my arm that mainly controls feeling or a specific movement.

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I have had a nerve injury due to an accident, stroke, or muscle disorder.

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I am scheduled for surgery immediately after my injury.

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I have nerve damage in my hand beyond the wrist crease.

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I have an injury to the nerves in my shoulder area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complications or problems that occur with in the first 30 days.

Secondary study objectives

Grip Strength

Motor Function

Pain Score

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PEG mediated reconstructionExperimental Treatment1 Intervention

NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy.

Group II: Conventional nerve reconstructionActive Control1 Intervention

Conventional nerve reconstruction

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NTX-001

2020

Completed Phase 2

~60

0 / 8Eligibility criteria met