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Procedure

NTX-001 for Peripheral Nerve Injury

Phase 2
Waitlist Available
Research Sponsored by Neuraptive Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
The surgical repair will occur within 48 hours of injury.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12, 24, 36 and 48
Awards & highlights

Study Summary

This trial is testing a new product that may help people with severed nerves.

Who is the study for?
This trial is for individuals aged 16-80 who have a single, sharply cut nerve injury that can be surgically repaired within 48 hours. The injury should be severe but repairable without too much tension. It's not for pregnant or breastfeeding women, those with serious health issues preventing surgery, or injuries involving blood vessel damage or gaps in the nerves.Check my eligibility
What is being tested?
The study tests NTX-001, a one-time surgical product used alongside standard nerve stitching techniques to repair severed nerves. Participants will receive this new treatment and their outcomes will be compared to those receiving the usual standard of care.See study design
What are the potential side effects?
Since NTX-001 is a surgical product used during nerve repair, side effects may include typical surgical risks such as infection, pain at the site of operation, swelling, and possible allergic reactions to the materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My nerve injury can be fixed with direct repair without much tension.
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My surgery is scheduled within 2 days of my injury.
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My nerve injury is severe, affecting the internal structure.
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I have a confirmed single cut nerve injury from surgery.
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I am between 16 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 24, 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Michigan Hand Questionnaire Total Score (MHQ)
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Secondary outcome measures
Cold Intolerance Symptom Severity (CISS)
Grip Strength
Modified British Medical Research Council (MMRC) motor grading (M0-M5)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NTX-001Experimental Treatment1 Intervention
NTX-001 used during surgical repair of an upper extremity peripheral nerve injury in conjuction with standard suture neurorrhaphy.
Group II: Standard of CareActive Control1 Intervention
standard suture neurorrhaphy

Find a Location

Who is running the clinical trial?

Neuraptive Therapeutics Inc.Lead Sponsor
3 Previous Clinical Trials
12 Total Patients Enrolled
Seth Schulman, MDStudy ChairNeuraptive Therapeutics Inc.
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

NTX-001 (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04572906 — Phase 2
Peripheral Nerve Injury Research Study Groups: NTX-001, Standard of Care
Peripheral Nerve Injury Clinical Trial 2023: NTX-001 Highlights & Side Effects. Trial Name: NCT04572906 — Phase 2
NTX-001 (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572906 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

What is the maximum sample size for this trial?

"The sponsor, Neuraptive Therapeutics Inc., needs to recruit 40 eligible patients from various locations including University Medical Center in New Orleans, Louisiana and University of Chicago in Chicago, Illinois."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~11 spots leftby Mar 2025