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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial studies an investigational drug to see if it can help people with spinal cord injury recover function.
Who is the study for?
This trial is for adults aged 18-75 with incomplete cervical spinal cord injury from physical trauma, able to take at least one step and have some hand grasp ability. They must be fluent in English, willing to follow the study plan, and not involved in another clinical trial or have certain medical conditions like severe pain, high BMI, or recent substance abuse.Check my eligibility
What is being tested?
The study tests NVG-291 on people with spinal cord injuries. It's a randomized (people are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), placebo-controlled (compared against an inactive substance) trial at Shirley Ryan AbilityLab.See study design
What are the potential side effects?
Potential side effects of NVG-291 aren't specified here but generally could include reactions where the drug is administered, flu-like symptoms, headaches, or other unforeseen issues as it's under investigation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrophysiological
Secondary outcome measures
10mWT time
9-HPT time
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NVG-291 for InjectionExperimental Treatment1 Intervention
Injected under the skin (subcutaneous).
Group II: PlaceboPlacebo Group1 Intervention
Injected under the skin (subcutaneous).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NVG-291
2021
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
NervGen PharmaLead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled
Daniel Mikol, M.D. Ph.D.Study DirectorNervGen Pharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal cord injury in the neck was caused by a sudden injury.I use opioids through spinal injection.I have taken 4-aminopyridine in the last 14 days.I am not currently undergoing, nor have I recently undergone, treatments like electrical stimulation to improve nerve function.I haven't had cancer, except for certain skin, cervical, or breast cancers, in the last 5 years.I have given or will give my written consent to participate.I rely on a machine to help me breathe.I have had seizures, but only fever-related ones are allowed.I have a metal implant in my head.My spine is unstable or narrowed due to an injury.I have had cell therapy directly into my brain or spinal cord.My severe nerve pain is not relieved by medication.I haven't taken any disallowed medications recently.I am either male or female.I am between 18 and 75 years old.My spinal cord injury is incomplete and located at my neck, C7 or higher.My spinal cord injury occurred between 1 and 10 years ago, or between 10 and 49 days ago.I can take a step without help.My walking ability is limited as per the WISCI II score requirements.My spinal cord injury is due to a disease, not an injury.My spinal cord injury was caused by a gunshot or similar injury.I am currently undergoing neuromuscular stimulation therapy.I have been treated with a PTPσ mimetic peptide before.I do not have any neurological conditions like MS, stroke, or syringomyelia.I do not have any conditions that prevent checking all my limbs properly.My kidney function is severely reduced.I can somewhat use at least one hand but not perfectly.I have more than one spinal cord lesion that are not next to each other.I have had botulinum toxin injections in my arm or leg muscles within the last 6 months.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: NVG-291 for Injection
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05965700 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I qualified to join this research endeavor?
"Appropriate applicants for this medical research are those between 18 and 75 years old with a spinal cord injury. At present, the trial is looking to enroll 40 participants."
Answered by AI
Does this research project accept subjects who are at least eighteen years of age?
"This study is currently seeking 18 to 75 year olds for participation. There are 148 trials that cater to individuals below the age of consent, and 756 studies targeting those over 65 years old."
Answered by AI
Is participation in this clinical experiment open to new applicants?
"As reported on the clinicaltrials.gov database, this medical trial is no longer actively seeking candidates; it was initially posted in August of 2023 and last updated at the end of July that same year. Despite this particular study ceasing patient recruitment, there are 932 other opportunities to participate across various trials currently available."
Answered by AI
Who else is applying?
What state do they live in?
Delaware
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to improve my overall health. Hopefully I can improve my bladder and bowel function, pain, and possibly even walk again. Hopefully I can improve on my trunk condition, fingers, wrists and hands functioning.
PatientReceived 1 prior treatment
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