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

Stopped early · Phase 2

Conditions studied: Facial Paralysis

In brief

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.

Key facts

Study ID

NCT05293522

Run by

Neuraptive Therapeutics Inc.

People needed

2

Starts

2022-07-12

Expected to finish

2023-08-22

Last updated by the study team

2023-09-11

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• University of Indiana — Indianapolis, Indiana, United States
• Washington University — St Louis, Missouri, United States
• Memorial Sloan Kettering — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Houston Methodist — Houston, Texas, United States

Full record on ClinicalTrials.gov

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