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

Facial Paralysis Clinical Trial

Official title:

A Phase 2a, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05293522
• Other study ID #: NTx21202
• Status: Terminated
• Phase: Phase 2
• Start date: July 12, 2022
• Est. completion date: August 22, 2023

Study information

• Verified date: September 2022
• Source: Neuraptive Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 complications, articulation difficulties, impaired feeding, and difficulty in conveying emotion through expressive movement. The current treatment for permanent facial paralysis is facial reanimation surgery, which encompasses a broad range of procedures that restore form and function to the paralyzed face.

The importance of understanding the health utility of facial paralysis and the value of facial reanimation surgery increases. PEG-fusion is a promising therapy for patients that have or will have nerve conditions or injuries resulting in facial palsy that can be addressed surgically. Patients that have clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis will be evaluated for participation. The primary objective is to assess the safety of NTX-001 across 12 months following the nerve repair. The study will measure improvement in Facial Grading System (FG) for efficacy. Additionally, measures will include an EMG evaluation for assessment of nerve function intraoperatively, image-based automatic facial landmark analysis, improvement in Facial Clinimetric Evaluation Scale score, and Patient Global Impression of Change Response (PGIC).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Paralysis

Intervention

Combination Product:
• NTX-001
2 solutions plus a delivery device; one time use surgical product

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Houston Methodist	Houston	Texas
United States	University of Indiana	Indianapolis	Indiana
United States	Memorial Sloan Kettering	New York	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Neuraptive Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraoperative EMG	Electromyography (EMG) measures amplitude and duration of facial motor unit action potentials which reflects in the number of innervated muscle fibers. This may demonstrate if reinnervation or nerve conduction has been restored in the operating room.	Once in the operating room.
Other	Image-based automatic facial landmark identification system	Image analysis automatically identifies facial landmarks and uses the position of those landmarks to estimate facial symmetry and/or evaluate facial neuromuscular diseases.	From screening visit, and at weeks 1, 6, 12, 24, 36, and 48.
Other	Facial Clinimetric Evaluation Scale	FaCE is a patient questionnaire that measures the patient's perception of their facial movement, facial comfort, oral function, eye comfort, tear control, and social function. Each one is scored separately to a total of 100, where 0 is the worst possible score to 100 is the best.	From screening visit, and at weeks 6, 12, 24, 36, and 48.
Other	Patient Global Impression of Change	PGIC is a patient questionnaire that evaluates the patients perception of their overall health status. A single-question with answers on a 7-point scale scored as: (1) "very much better," (2) "much better," (3) "a little better," (4) "no change," (5) "a little worse," (6) "much worse," or (7) "very much worse." The following ranges demonstrate disease worsening (0-3 points), stable disease (4 points) or disease improvement (5-7 points) since the initial baseline or prior assessment.	From screening visit, and at weeks 6, 12, 24, 36, and 48.
Primary	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..
Primary	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.