Status:
TERMINATED
A Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.
Lead Sponsor:
Neuraptive Therapeutics Inc.
Conditions:
Facial Paralysis
Eligibility:
All Genders
12-80 years
Phase:
PHASE2
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...
Detailed Description
Facial paralysis can be a consequence of traumatic facial nerve injury, iatrogenic causes, malignancy, congenital syndromes, and viral infections. Prolonged paralysis can result in ocular complication...
Eligibility Criteria
Inclusion
- The subject has clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis.
Exclusion
- 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.
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05293522
Start Date
July 12 2022
End Date
August 22 2023
Last Update
September 11 2023
Active Locations (6)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
University of Indiana
Indianapolis, Indiana, United States, 46202
3
Washington University
St Louis, Missouri, United States, 63130
4
Memorial Sloan Kettering
New York, New York, United States, 10065