NCT05293522

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

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Neuraptive Therapeutics Inc. · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Facial Paralysis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NTX-001	2 solutions plus a delivery device; one time use surgical product

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2022-03-24
• Last updated: 2023-09-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study