NVG-291 in Spinal Cord Injury Subjects

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injuries, Chronic Spinal Cord Injury, Subacute Spinal Cord Injury

In brief

A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2a Study of NVG-291 in Spinal Cord Injury Subjects

Key facts

Study ID

NCT05965700

Run by

NervGen Pharma

People needed

24

Starts

2023-08-08

Expected to finish

2026-01-21

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject must provide written informed consent in accordance with local regulations prior to initiation of any study-specific activities/procedures. A legally authorized representative (LAR) may be used to assist in signing the informed consent.
• Cervical SCI resulting from acute physical trauma.
• Males and females
• Age 18 - 75 years, inclusive.
• Cervical SCI, incomplete, with a neurological level of injury being at C7 or higher.
• Had incomplete cervical SCI within the period from 1 year to 10 years inclusive (Chronic cohort 1) OR within 20 days to 90 days inclusive (Subacute cohort 2) at time of randomization.
• Must be able to volitionally initiate at least one step on one leg (without body weight support). (Cohort 1 only)
• Must have a Walking Index for Spinal Cord Injury II (WISCI II) score as follows:
• For Chronic cohort 1: Less than or equal to Level 14.
• For Subacute cohort 2: Less than or equal to Level 10.
• GRASSP/hand grip strength Prehension Ability score
• For Chronic cohort 1:
• i. Must have a score of at least 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment in at least one upper extremity. ii. Must have no more than one Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i
• For Subacute cohort 2:
• i. Must have some voluntary (nonzero) force measured by grip dynamometry in at least one upper extremity.
• ii. Must have no more than one Prehension Ability grasp patterns score = 3 in at least one upper extremity.
• iii. Must not have a Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion.
• Presence of Motor Evoked Potentials (MEPs):
• In two specific target muscle groups (Cohort 1)
• In one specific target muscle group (Cohort 2)
• Must be fluent in English.
• Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.

You may not qualify if…

• Nontraumatic SCI (e.g., due to infection, ischemia, metabolic abnormality, congenital abnormality, malignancy, radiation injury, surgical complications, or other disease process).
• Spinal cord injury due to gunshot wound or penetrating injury.
• Two or more (noncontiguous) spinal cord lesions.
• MRI or CT evidence of anatomically complete spinal cord transection.
• Any form of ventilatory dependence.
• Any condition that precludes adequate clinical assessment of all four extremities, such as contracture, peripheral nerve injury, amputation.
• History of uncontrolled seizures or any seizure within the last 6 months (Cohort 1). History of uncontrolled seizures, or any seizure occurring 1 week or more after the SCI (Cohort 2)
• Metal implant in the head that is likely to interfere with MRI analysis.
• Pregnant or breast feeding.
• Any neurological condition that is considered to interfere with performance or likly confound assessment, such as multiple sclerosis, stroke, or progressive syringomyelia.
• History of substance abuse within 12 months prior to screening, based on medical records or self-report.
• Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma.
• Prior treatment with cell therapy delivered into the CNS (intrathecal or intraparenchymal).
• Severe neuropathic pain inadequately controlled by medication.
• Body mass index (BMI) > 40 (body weight in kilograms divided by height in meters squared).
• Received botulinum toxin injection(s) in an upper or lower extremity muscle in the prior 6 months.
• Received 4-aminopyridine within 7 days of first dose..
• Prior treatment with a protein tyrosine phosphatase sigma (PTPσ) mimetic peptide.
• Intrathecal opioid use.
• Currently participating in an interventional clinical trial.
• Received a non-permitted medication within 5.5 half-lives or 7 days, whichever is longer, prior to randomization
• Receiving any treatment intended to enhance neuroplasticity (e.g., electrical stimulation, acute intermittent hypoxia) at the time of consent to participate in this study or within 4 weeks of randomization, whichever is longer.
• Any implanted internal spinal cord stimulator.
• Currently receiving neuromuscular stimulation.
• Currently receiving vagal or phrenic nerve stimulation.

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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