Clinical trial NCT05293522: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Facial Paralysis
Keywords: Parotidectomy
Nerve Transfers
Free functional muscle flaps
Lead sponsor: Neuraptive Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Adverse Events for Safety
timeFrame: Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
measure: Sunnybrook Facial Grading System
timeFrame: From screening visit, and at weeks 6, 12, 24, 36, and 48.
Secondary outcomes:
Other outcomes:
measure: Intraoperative EMG
timeFrame: Once in the operating room.
measure: Image-based automatic facial landmark identification system
timeFrame: From screening visit, and at weeks 1, 6, 12, 24, 36, and 48.
measure: Facial Clinimetric Evaluation Scale
timeFrame: From screening visit, and at weeks 6, 12, 24, 36, and 48.
measure: Patient Global Impression of Change
timeFrame: From screening visit, and at weeks 6, 12, 24, 36, and 48.
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: University of Indiana
state: Indiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: Seth Schulman, MD
role: STUDY_DIRECTOR
References: