A Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.

NCT05293522 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: NTx21202
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

Brief Summary

This study involves the use of an Investigational Product called NTX-001. It is a product used in the repair of nerve injuries. It is used in the operating room. The main purposes of this study are to 1) see how safe NTX-001 is when used in nerve repair and, 2) see if your nerve becomes functional in a shorter period of time when compared to what is normally done to treat nerve injuries.

Conditions

Facial Paralysis

Keywords

Parotidectomy; Nerve Transfers; Free functional muscle flaps

Outcome Measures

Primary Outcomes (2)

• Adverse Events for Safety

  Measuring the safety of NTX-001 following the nerve repair based on the number of reported adverse events.

  Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..

• Sunnybrook Facial Grading System

  Change in Sunnybrook Facial Grading score from baseline as compared to Week 6;

  From screening visit, and at weeks 6, 12, 24, 36, and 48.

Other Outcomes (4)

• Intraoperative EMG

  Once in the operating room.

• Image-based automatic facial landmark identification system

  From screening visit, and at weeks 1, 6, 12, 24, 36, and 48.

• Facial Clinimetric Evaluation Scale

  From screening visit, and at weeks 6, 12, 24, 36, and 48.

Study Arms (2)

NTX-001

EXPERIMENTAL

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

Combination Product: NTX-001

Standard of Care

NO INTERVENTION

Standard neurorrhaphy

Interventions

NTX-001 COMBINATION_PRODUCT

2 solutions plus a delivery device; one time use surgical product

NTX-001

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis.

You may not qualify if:

• Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
• Subjects requiring repair of the intracranial portion of the facial nerve. Subjects requiring repair involving an allograft or conduit except for procedures that require grafting of the other nerve branches when repairing the main facial nerve.
• Subjects with Bell's palsy that have signs of spontaneous recovery by 12 months.
• Subjects who, in the judgment of the investigator, are not likely to demonstrate meaningful recovery within 6 weeks due to significant facial muscle atrophy.
• Subjects on chronic corticosteroid therapy within 14 days of repair.
• The subject has documented history or clinical signs of:
• Clinically significant neuropathy from any cause i.e., medications, chemotherapy, diabetes; Clinically significant systemic neuromuscular disease; Clinically significant local or systemic neurological deficit from other than the condition under study such as stroke; Or other treatments are known to affect the growth and/or physiology of the neural and vascular system with the exception of radiation therapy; The subject has a known allergy to polyethylene glycol (PEG) or human-grade silicone.
• The subject is not able to strictly adhere to the rules of the current clinical protocol, e.g., significant mental health issues, homelessness, incarceration, intellectually or developmentally challenged without proper legal representation.

Sponsors & Collaborators

• Neuraptive Therapeutics Inc.: lead

Study Sites (6)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710-1000, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seth Schulman, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 24, 2022
• Study Start: July 12, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: September 11, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)