Clinical trial NCT06616025: This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
Official title: Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Peripheral Nerve Injury Upper Limb
Peripheral Nerve Injury (PNI)
Keywords: Transected Nerves
Requiring Surgical Repair
Upper Extremity
Lead sponsor: Neuraptive Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment vs. Standard of Care
Primary purpose: TREATMENT

Brief summary: NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.

Detailed description: NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. 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 determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.

Eligibility criteria: Inclusion Criteria:

* The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
* The subject is between eighteen (18) and eighty (80) years of age.
* The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.

Exclusion Criteria:

* Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
* Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
* Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
* Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.
* The subject's injury is a result of a suicide attempt or self- harm.
* The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
* The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
* The subject is pregnant or breastfeeding.
* The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.

Primary outcomes:
measure: Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
timeFrame: Screening Visit, Week 24
Secondary outcomes:
measure: Intraoperative CheckPoint® Stimulation.
timeFrame: In Operating Room
measure: Electromyography (EMG) Testing
timeFrame: Weeks 12, 24.
measure: Nerve Conduction Velocity (NCV)
timeFrame: Weeks 12, 24
measure: MHQ Total Score
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48
measure: Time to Return to Function
timeFrame: Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
measure: Change in NPRS
timeFrame: Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48
measure: Semmes Weinstein Monofilament Test (SWMT)
timeFrame: Weeks 2, 4, 8, 12, 24, 36, 48.
measure: MHQ Two Domain Score
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48
measure: Change from Week 2 in MHQ Two Domain Score
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
measure: Medical Research Council Classification (MRCC) Sensory Score
timeFrame: Weeks 2, 4, 8, 12, 24, 36, and 48.
measure: Medical Research Council Classification (MRCC) Motor Score
timeFrame: Weeks 2, 4, 8, 12, 24, 36, 48
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Screening Visit, Weeks 4, 12 and 48
measure: Change from Baseline (W2) in Numeric Pain Rating Scale (NPRS)
timeFrame: Weeks 2, 24.
measure: Patient Global Impression of Change Score
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48
measure: Change in Total MHQ Score
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
measure: Patient Global Impression of Change Score (PGIC)
timeFrame: Week 24
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Curtis National Center at MedStar Union Memorial Hospital
state: Maryland
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
state: Missouri
Study officials:
affiliation: Neuraptive Therapeutics Inc.
name: Seth Schulman, MD
role: STUDY_DIRECTOR
References: