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

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ClinicalTrials.gov Identifier: NCT05293522
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Neuraptive Therapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Facial Paralysis Combination Product: NTX-001 Phase 2

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 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 Sunnybrook Facial Grading System (SB) 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 12, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NTX-001
Solution #1, Solution #2 Active, Solution #3
Combination Product: NTX-001
2 solutions plus a delivery device; one time use surgical product

No Intervention: Standard of Care
Standard neurorrhaphy



Primary Outcome Measures :
  1. Adverse Events for Safety [ Time Frame: Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year.. ]
    Measuring the safety of NTX-001 following the nerve repair based on the number of reported adverse events.

  2. Sunnybrook Facial Grading System [ Time Frame: From screening visit, and at weeks 6, 12, 24, 36, and 48. ]
    Change in Sunnybrook Facial Grading score from baseline as compared to Week 6;


Other Outcome Measures:
  1. Intraoperative EMG [ Time Frame: Once in the operating room. ]
    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.

  2. Image-based automatic facial landmark identification system [ Time Frame: From screening visit, and at weeks 1, 6, 12, 24, 36, and 48. ]
    Image analysis automatically identifies facial landmarks and uses the position of those landmarks to estimate facial symmetry and/or evaluate facial neuromuscular diseases.

  3. Facial Clinimetric Evaluation Scale [ Time Frame: From screening visit, and at weeks 6, 12, 24, 36, and 48. ]
    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.

  4. Patient Global Impression of Change [ Time Frame: From screening visit, and at weeks 6, 12, 24, 36, and 48. ]
    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.



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293522


Contacts
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Contact: Seth Schulman, MD 617-416-4520 seth.schulman@neuraptive.com
Contact: Vicki J Abbas, BSN RN 303-263-4646 vicki.abbas@neuraptive.com

Locations
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United States, Indiana
University of Indiana Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Greg Borschel, MD    317-992-5248    gborsche@iu.edu   
United States, Missouri
Washington University Not yet recruiting
Saint Louis, Missouri, United States, 63130
Contact: Alison K. Snyder-Warwick, MD    314-454-4004    snydera@wustl.edu   
Contact: Amanda Westman    314-362-4583    a.m.westman@wustl.edu   
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710-1000
Contact: Brett Phillips, MD, MBA, FACS    919-684-5237    brett.phillips@duke.edu   
United States, Texas
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Michael Klebuc, MD    832-465-0275    mklebuc@msn.com   
Contact: Kelly J Maresh, MBA, BSN, RN    281-881-6408    kjmaresh@houstonmethodist.org   
Sponsors and Collaborators
Neuraptive Therapeutics Inc.
Investigators
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Study Director: Seth Schulman, MD Chief Medical Officer
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Responsible Party: Neuraptive Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05293522    
Other Study ID Numbers: NTx21202
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neuraptive Therapeutics Inc.:
Parotidectomy
Nerve Transfers
Free functional muscle flaps
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Facies
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Facial Nerve Diseases
Cranial Nerve Diseases