Your session is about to expire
← Back to Search
Other
NTX-001 for Facial Palsy
Phase 2
Waitlist Available
Research Sponsored by Neuraptive Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
Awards & highlights
Study Summary
This trial is testing an investigational product called NTX-001 for safety and effectiveness in repairing nerve damage. Researchers will compare NTX-001 to the current standard of care to see if it leads to faster nerve function recovery.
Eligible Conditions
- Facial Palsy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events for Safety
Sunnybrook Facial Grading System
Other outcome measures
Facial Clinimetric Evaluation Scale
Image-based automatic facial landmark identification system
Intraoperative EMG
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NTX-001Experimental Treatment1 Intervention
Solution #1, Solution #2 Active, Solution #3
Group II: Standard of CareActive Control1 Intervention
Standard neurorrhaphy
Find a Location
Who is running the clinical trial?
Neuraptive Therapeutics Inc.Lead Sponsor
3 Previous Clinical Trials
61 Total Patients Enrolled
Seth Schulman, MDStudy DirectorChief Medical Officer
1 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have Bell's palsy, but if you show signs of getting better on your own within a year, you won't be included in the study.You need surgery to fix the facial nerve inside your head.You need a specific type of surgery that involves using someone else's tissue, except if it's for repairing the main facial nerve.You have facial paralysis that needs treatment or repair due to a condition or procedure that may cause or has caused paralysis.Your facial muscles are severely weakened and unlikely to recover within 6 weeks.You have a history of significant nerve problems or neurological conditions that are not related to the condition being studied. You also have an allergy to polyethylene glycol (PEG) or human-grade silicone.
Research Study Groups:
This trial has the following groups:- Group 1: NTX-001
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Facial Palsy Patient Testimony for trial: Trial Name: NCT05293522 — Phase 2
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger