Back to resultsA Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.
Primary Purpose
Facial Paralysis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NTX-001
Sponsored by
About this trial
This is an interventional treatment trial for Facial Paralysis focused on measuring Parotidectomy, Nerve Transfers, Free functional muscle flaps
Eligibility 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.
Sites / Locations
- Rush University Medical Center
- University of Indiana
- Washington University
- Memorial Sloan Kettering
- Duke University Medical Center
- Houston Methodist
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NTX-001
Standard of Care
Arm Description
Solution #1, Solution #2 Active, Solution #3
Standard neurorrhaphy
Outcomes
Primary Outcome Measures
Adverse Events for Safety
Measuring the safety of NTX-001 following the nerve repair based on the number of reported adverse events.
Sunnybrook Facial Grading System
Change in Sunnybrook Facial Grading score from baseline as compared to Week 6;
Secondary Outcome Measures
Full Information
NCT ID
NCT05293522
First Posted
February 14, 2022
Last Updated
September 6, 2023
Sponsor
Neuraptive Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05293522
Brief Title
A Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Enrollment Rate
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
August 22, 2023 (Actual)
Study Completion Date
August 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuraptive Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralysis
Keywords
Parotidectomy, Nerve Transfers, Free functional muscle flaps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NTX-001
Arm Type
Experimental
Arm Description
Solution #1, Solution #2 Active, Solution #3
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard neurorrhaphy
Intervention Type
Combination Product
Intervention Name(s)
NTX-001
Intervention Description
2 solutions plus a delivery device; one time use surgical product
Primary Outcome Measure Information:
Title
Adverse Events for Safety
Description
Measuring the safety of NTX-001 following the nerve repair based on the number of reported adverse events.
Time Frame
Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
Title
Sunnybrook Facial Grading System
Description
Change in Sunnybrook Facial Grading score from baseline as compared to Week 6;
Time Frame
From screening visit, and at weeks 6, 12, 24, 36, and 48.
Other Pre-specified Outcome Measures:
Title
Intraoperative EMG
Description
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.
Time Frame
Once in the operating room.
Title
Image-based automatic facial landmark identification system
Description
Image analysis automatically identifies facial landmarks and uses the position of those landmarks to estimate facial symmetry and/or evaluate facial neuromuscular diseases.
Time Frame
From screening visit, and at weeks 1, 6, 12, 24, 36, and 48.
Title
Facial Clinimetric Evaluation Scale
Description
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.
Time Frame
From screening visit, and at weeks 6, 12, 24, 36, and 48.
Title
Patient Global Impression of Change
Description
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.
Time Frame
From screening visit, and at weeks 6, 12, 24, 36, and 48.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Schulman, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-1000
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.
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