NTX-001 for Facial Palsy

No longer recruiting at 6 trial locations

Overseen By Vicki J Abbas, BSN RN

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Neuraptive Therapeutics Inc.

Must not be taking: Corticosteroids

Disqualifiers: Neuropathy, Neuromuscular disease, Stroke, others

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

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NTX-001, also known as Polyethylene Glycol (PEG) Mediated Fusion, used in surgeries to repair nerve injuries and speed up nerve function recovery. Researchers aim to determine if this treatment is safe and promotes faster nerve healing compared to standard methods. Individuals with facial paralysis requiring nerve repair, who haven't shown signs of recovery, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on chronic corticosteroid therapy within 14 days of the nerve repair.

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

Research has shown that NTX-001, which contains polyethylene glycol (PEG), is generally safe for nerve repair. Studies have found that PEG can help drugs last longer in the body and is safe to use with other medical products. In earlier research, patients who used NTX-001 for nerve injuries did not experience any serious side effects, suggesting that NTX-001 is well-tolerated. However, as this trial remains in the early stages, its safety continues to be carefully studied. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NTX-001 for treating facial paralysis because it offers a novel approach compared to the current standard, which typically involves surgical repair like neurorrhaphy. NTX-001 is an experimental solution designed to address nerve damage directly, potentially enhancing nerve healing and reducing the need for invasive procedures. This treatment is unique because it targets the underlying cause of paralysis rather than just managing symptoms, which could lead to quicker recovery times and better outcomes for patients. Its innovative mechanism of action sets it apart from traditional surgical methods, making it a promising option for those facing facial paralysis.

What evidence suggests that NTX-001 might be an effective treatment for nerve injuries?

Research has shown that NTX-001, a treatment using polyethylene glycol (PEG), helps nerves heal faster. Studies have found that PEG can directly connect nerve ends, allowing them to heal without the usual long process known as Wallerian degeneration. In some cases, patients quickly regained feeling in their fingers after treatment with PEG. This trial will compare NTX-001 with the standard of care, which involves standard neurorrhaphy. These findings suggest that NTX-001 could help people recover nerve function faster than traditional methods. Overall, early evidence indicates that NTX-001 may be an effective option for treating nerve injuries requiring surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

Seth Schulman, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

Inclusion Criteria

You have facial paralysis that needs treatment or repair due to a condition or procedure that may cause or has caused paralysis.

Exclusion Criteria

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.

Subjects whose nerve repair will occur greater than 48 hours after nerve transection.

Subjects on chronic corticosteroid therapy within 14 days of repair.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo surgical repair with NTX-001 and standard neurorrhaphy, including intraoperative EMG evaluation

1 week

1 visit (in-person, operating room)

Follow-up

Participants are monitored for safety and efficacy, including assessments of facial movement and nerve function

48 weeks

Visits at weeks 6, 12, 24, 36, and 48 (in-person)

Long-term follow-up

Participants may continue to be monitored for long-term safety and efficacy outcomes

Additional months beyond 48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NTX-001

How Is the Trial Designed?

Group I: NTX-001 Experimental Treatment 1 Intervention

Solution #1, Solution #2 Active, Solution #3

Group II: Standard of Care Active Control 1 Intervention

Standard neurorrhaphy

Who Is Running the Clinical Trial?

Neuraptive Therapeutics Inc.

Lead Sponsor

Trials

5

Recruited

160+

Published Research Related to This Trial

A study estimated PEG exposure in children receiving PEGylated therapies for hemophilia, revealing significant annual exposure levels without any reported adverse effects, suggesting long-term safety.

For a 50 kg child on the highest prophylactic dose of FVIII, PEG exposure ranged from 40 to 21,840 mg/year, yet no adverse event patterns related to PEG were identified, indicating that PEG is likely safe for pediatric use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. Stidl, R., Denne, M., Goldstine, J., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04789044

Evaluating the Safety and Efficacy of Polyethylene Glycol ... The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36744063/

Rapid and effective fusion repair of severed digital nerves ... We now describe PEG-mediated fusion repair of a digital nerve in each of two patients presenting with a digital laceration resulting in total loss of sensation.

3. jhsgo.org jhsgo.org/article/S2589-5141(24)00031-8/fulltext

Polyethylene Glycol Fusion and Nerve Repair Success This article summarizes the background, current evidence, and future directions as well as potential applications of polyethylene glycol–mediated nerve fusion.

4. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1168738.pdf

Polyethylene Glycol (PEG)-Mediated Fusion (PEG ... - DTIC The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0974322724002886

Polyethylene Glycol Fusion of Nerve Injuries Investigational techniques in nerve repair using polyethylene glycol (PEG) nerve fusion have been shown to bypass Wallerian degeneration.

6. withpower.com withpower.com/trial/phase-3-peripheral-nerve-injuries-9-2021-3853f?condition=&query=Topical+Agents&overallStatus=Recruiting&hasNoPlacebo=false

PEG Fusion for Peripheral Nerve Injury This Phase 2 medical study run by Major Extremity Trauma Research Consortium is evaluating whether NTX-001 and PEG Fusion will have tolerable side effects ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04789044?keyword=%22Peripheral%20Nerve%20Injuries%22

San Mateo Clinical Trial Evaluating the Safety and Efficacy ... The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6471459/

Polyethylene Glycol: The Future of Posttraumatic Nerve ... PEG therapy is a promising prospect that may improve the surgical treatment of peripheral nerve injuries in the clinical practice.