NTX-001 for Peripheral Nerve Injury

Recruiting at 7 trial locations

Overseen By Kristen Olszyk, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Neuraptive Therapeutics Inc.

Disqualifiers: Muscle atrophy, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NTX-001, used during surgery to repair damaged nerves in the arm. The goal is to determine if NTX-001 can enhance nerve healing when combined with standard surgical methods. Participants suitable for this trial have a severe nerve injury in their upper arm requiring surgical repair. The trial compares usual surgical care to surgery with NTX-001 to assess which is more effective. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that NTX-001 is likely to be safe for humans?

Earlier studies tested NTX-001 for safety and effectiveness in aiding nerve healing after surgery. Research so far shows that NTX-001 is generally safe for use. This treatment aims to speed up nerve recovery following surgical repair.

The studies include trials where participants are randomly assigned to different groups, with some receiving standard treatments. This design helps researchers compare results and ensure NTX-001's effectiveness and safety. Although detailed safety results aren't available, the treatment's progression to Phase 3 trials indicates it has passed earlier safety checks. Additionally, NTX-001 has received FDA Breakthrough Therapy status, suggesting it might offer significant benefits over current treatments.

Overall, NTX-001 appears well-tolerated, with no major safety concerns reported. However, like any treatment, risks exist, and side effects may vary among individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for peripheral nerve injuries, which typically involves just surgical repair with sutures, NTX-001 offers an enhanced approach. NTX-001 is used alongside the standard suture technique, potentially improving nerve repair outcomes. Researchers are excited because NTX-001 might enhance the healing process more effectively than sutures alone, possibly leading to better functional recovery for patients.

What evidence suggests that NTX-001 is effective for peripheral nerve injury?

Research has shown that NTX-001, which participants in this trial may receive, might aid in nerve healing for those with injuries to the nerves in their arms or hands. Studies have found that NTX-001 can safely accelerate the return of nerve function, which typically takes a long time. Surgeons use this product during procedures to reconnect cut nerves, and early results suggest it can make the healing process faster and more complete. This trial tests the device to confirm these benefits, aiming to help patients regain feeling and movement more quickly. ^{1 2 3 6 7}

Who Is on the Research Team?

Seth Schulman, MD

Principal Investigator

Neuraptive Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with severe upper extremity nerve injuries that need surgery. Participants must have a specific type of nerve damage (Sunderland's 4th or 5th degree) and be willing to sign a consent form.

Inclusion Criteria

I have severe nerve damage in my arm that needs surgery.

I have agreed to join this study and signed the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgical Treatment

Participants undergo surgical repair of upper extremity peripheral nerve injury using NTX-001 in conjunction with standard suture neurorrhaphy

Intraoperative

1 visit (in-person, in operating room)

Post-operative Monitoring

Participants are monitored for safety and effectiveness of the surgical treatment, including pain assessment and nerve function tests

48 weeks

Regular visits at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48

Follow-up

Participants are monitored for long-term safety and effectiveness after the main treatment phase

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NTX-001

Trial Overview The study tests NTX-001, a one-time surgical product used alongside standard stitching techniques for repairing severed nerves during surgery.

How Is the Trial Designed?

Group I: NTX-001 Experimental Treatment 1 Intervention

NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.

Group II: Standard Suture Neurorrhaphy Active Control 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

Neuraptive Therapeutics Inc.

Lead Sponsor

Trials

5

Recruited

160+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04572906

Safety and Efficacy of NTX-001 Compared to SOC in Acute ... NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06616025?cond=%22Neuromuscular+Disorders%22&term=%22Washington+University+School+of+Medicine+in+St.+Louis%22+OR+%22Washington+University+in+St.+Louis%22+OR+%22St.+Louis+Children%27s+Hospital%22+OR+%22Barnes-Jewish+Hospital%22

This Study Will Evaluate the Effectiveness of NTX-001, a ... This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.

3. biospace.com biospace.com/press-releases/neuraptive-therapeutics-inc-announces-first-patient-enrolled-in-phase-3-clinical-trial-evaluating-the-safety-and-efficacy-of-ntx-001-compared-to-standard-of-care-in-the-treatment-of-upper-extremity-transected-nerves-requiring-surgical-repair

Neuraptive Therapeutics, Inc. Announces First Patient ... The phase 3 study is a multicenter, randomized, subject and evaluator blinded, controlled study evaluating the safety and efficacy of NTX-001 ...

4. businesswire.com businesswire.com/news/home/20240911372663/en/Neuraptive-Therapeutics-Receives-FDA-Breakthrough-Therapy-Designation-for-NTX-001-and-Provides-Update-on-the-Advancements-of-NTX-001-for-the-Treatment-of-Peripheral-Nerve-Injury-Requiring-Repair

Neuraptive Therapeutics Receives FDA Breakthrough ... The program will consist of a single randomized, double-blind, placebo-controlled study assessing the efficacy and safety of NTX-001 in patients ...

5. ctv.veeva.com ctv.veeva.com/study/this-study-will-evaluate-the-effectiveness-of-ntx-001-a-surgical-nerve-repair-product-when-used-in

This Study Will Evaluate the Effectiveness of NTX-001, a ... Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to ...

6. pharmaceutical-technology.com pharmaceutical-technology.com/news/fda-btd-neuraptive-ntx-001/

FDA grants breakthrough therapy status for Neuraptive's ... The programme will include a randomised, double-blind, placebo-controlled trial to evaluate the safety and efficacy of NTX-001 in patients with ...

7. neuraptive.com neuraptive.com/company

Company Neuraptive Therapeutics is a biotechnology company developing novel therapies to potentially improve outcomes in peripheral nerve injuries, or PNI.