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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
No Placebo-Only Group
Summary
This trial tests NTX-001, a new treatment used during surgery to help repair damaged nerves. It targets patients with facial paralysis from various causes who have ongoing issues like difficulty moving their face and speaking. The treatment aims to speed up and improve nerve healing, helping patients regain facial movement sooner.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events for Safety
Sunnybrook Facial Grading System
Other study objectives
Facial Clinimetric Evaluation Scale
Image-based automatic facial landmark identification system
Intraoperative EMG
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
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Who is running the clinical trial?
Neuraptive Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled
Seth Schulman, MDStudy DirectorChief Medical Officer
2 Previous Clinical Trials
149 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
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