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

NCT05293522 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • Facial Paralysis

Interventions

COMBINATION_PRODUCT

NTX-001

2 solutions plus a delivery device; one time use surgical product

Sponsors & Collaborators

  • Neuraptive Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Seth Schulman, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2023-08-22
Completion
2023-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293522 on ClinicalTrials.gov