NTX-001 Peripheral Nerve Injury Study
A Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring below the Distal Border of the Brachial Plexus Requiring Surgical Repair.
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Clinical Trial Information
Trial Contact: Krol, David; Harriott, Paula; Valesquez, Damaris
Trial Phone: 321.843.5687 ; 321.841.3867 ; 321-842-9415
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IRB No: 21.137.08
Protocol Abbrev: NTX
Principal Investigator: Justin William Zumsteg, MD
Phase: Drug: Phase II
Age Group: Adult;Pediatric
Secondary Protocol No: NTx20201
Treatment: NTX-001
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04572906
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Objective
Primary Objectives:
● To assess the safety of NTX-001 across 48 weeks (12 Months) following the surgical repair of a peripheral nerve injury occurring below the distal border of the brachial plexus.
● To assess functionality using MHQ Total Score at Week 12 following the surgical repair of a peripheral nerve injury occurring below the distal border of the brachial plexus.
Exploratory Secondary Objectives:
● To assess electrophysiologic (EP) continuity after NTX-001 treatment; stratified by injury location.
● To assess improvement from baseline in the following assessments when NTX-001 is used in conjunction with standard suture neurorrhaphy:
o British Medical Research Council Classification (MRCC) sensory scale, and/or the MRCC motor scale (based on location of injury)
o Semmes Weinstein Monofilament Test (SWMT)
o Grip/Pinch Strength
o Michigan Hand Questionnaire (MHQ)
o Cold Intolerance Symptom Severity (CISS)
o Patient Global Impression of Change (PGIC)
o Numeric Pain Rating Scale (NPRS) -
Key Eligibility
The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury;
a. Involves injury to motor and/or sensory function of the radial, median, or ulnar nerve with injury localized distal to the brachial plexus cord level to the fingertip;
b. Multiple transected digital nerves of the hand are allowed; with each digital repair which will follow the randomization CONFIDENTIAL Page 13 of 97
assignment resulting from upper extremity trauma meeting the following criteria.
4. The subject’s nerve injury is classified as Sunderland’s Fourth and Fifth Degree (Class III).
5. The subject’s nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
6. The surgical repair will occur within 48 hours of injury.
7. The subject is willing to comply with all aspects of the treatment and evaluation schedule over the active study period.
