Facial ParalysisPhase 2NCT05293522
A Study of NTX-001 in the Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.
A Phase 2 study testing NTX-001 in people with Facial Paralysis, run by Neuraptive Therapeutics Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- NTX-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Jul 2022to 22 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject has clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rush University Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710-1000
Houston Methodist
Houston, Texas, 77030
University of Indiana
Indianapolis, Indiana, 46202
Memorial Sloan Kettering
New York, New York, 10065
Washington University
St Louis, Missouri, 63130
About this study
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.
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.
Read the 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
- Being tested
- NTX-001
- Keywords
- Parotidectomy, Nerve Transfers, Free functional muscle flaps
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-001Combination product
2 solutions plus a delivery device; one time use surgical product
| Study group | Role | What they receive |
|---|---|---|
| NTX-001 | Experimental | Solution #1, Solution #2 Active, Solution #3 Receives: Combination Product: NTX-001 |
| Standard of Care | No intervention | Standard neurorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events for Safety
Measuring the safety of NTX-001 following the nerve repair based on the number of reported adverse events.
Measured: Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
Sunnybrook Facial Grading System
Change in Sunnybrook Facial Grading score from baseline as compared to Week 6;
Measured: From screening visit, and at weeks 6, 12, 24, 36, and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start12 Jul 2022
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Why it stopped: Enrollment Rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuraptive Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seth Schulman, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293522
- Sponsor's protocol ID
- NTx21202
- Status last verified
- Sep 2022
- First submitted
- 14 Feb 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05293522
- Acronym / sponsor ID
- NTx21202
- Conditions
- Facial Paralysis
- Keywords
- Parotidectomy, Nerve Transfers, Free functional muscle flaps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Rate
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Neuraptive Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTX-001 | Experimental | Combination Product: NTX-001Solution #1, Solution #2 Active, Solution #3 |
| Standard of Care | No intervention | –Standard neurorrhaphy |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The subject has clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-0012 solutions plus a delivery device; one time use surgical product | Combination product | NTX-001 |
Primary outcome
Adverse Events for Safety
Time frame: Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..
Measuring the safety of NTX-001 following the nerve repair based on the number of reported adverse events.
Sunnybrook Facial Grading System
Time frame: From screening visit, and at weeks 6, 12, 24, 36, and 48.
Change in Sunnybrook Facial Grading score from baseline as compared to Week 6;
Results and safety
The study was stopped early (reason given: Enrollment Rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Facial Paralysis
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Schulman, MD study director
Chief Medical Officer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTX-001 in people with Facial Paralysis, run by Neuraptive Therapeutics Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment Rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events for Safety (time frame: Adverse events will be assessed and recorded from start of study through 48 weeks or approximately 1 year..). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.