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
|Condition or disease||Intervention/treatment||Phase|
|Facial Paralysis||Combination Product: NTX-001||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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;
- 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.
- 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.
- 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.
- 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.
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
|Contact: Seth Schulman, MDfirstname.lastname@example.org|
|Contact: Vicki J Abbas, BSN RNemail@example.com|
|United States, Indiana|
|University of Indiana||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Greg Borschel, MD 317-992-5248 firstname.lastname@example.org|
|United States, Missouri|
|Washington University||Not yet recruiting|
|Saint Louis, Missouri, United States, 63130|
|Contact: Alison K. Snyder-Warwick, MD 314-454-4004 email@example.com|
|Contact: Amanda Westman 314-362-4583 firstname.lastname@example.org|
|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 email@example.com|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Contact: Michael Klebuc, MD 832-465-0275 firstname.lastname@example.org|
|Contact: Kelly J Maresh, MBA, BSN, RN 281-881-6408 email@example.com|
|Study Director:||Seth Schulman, MD||Chief Medical Officer|