Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05965700

NVG-291 in Spinal Cord Injury Subjects

Led by NervGen Pharma · Updated on 2026-03-06

40

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

NVG-291 in Spinal Cord Injury Subjects

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent or have a legally authorized representative do so
  • Have cervical spinal cord injury caused by acute physical trauma
  • Be male or female
  • Be 18 to 75 years old
  • Have incomplete cervical spinal cord injury at level C7 or higher
  • Have had incomplete cervical SCI between 1 and 10 years ago (Chronic cohort) or between 20 and 90 days ago (Subacute cohort) at randomization
  • Be able to voluntarily initiate at least one step on one leg without body weight support (Chronic cohort only)
  • Have a Walking Index for Spinal Cord Injury II (WISCI II) score of 14 or less (Chronic cohort) or 10 or less (Subacute cohort)
  • Have a GRASSP/hand grip strength Prehension Ability score of at least 2 on one grasp pattern and no more than one grasp pattern score of 4 in the upper extremity (Chronic cohort)
  • Have some voluntary grip force and no more than one grasp pattern score of 3 or any score of 4 in the upper extremity (Subacute cohort)
  • Have Motor Evoked Potentials in two target muscles (Chronic cohort) or one target muscle (Subacute cohort)
  • Be fluent in English
  • Be willing and able to comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Have nontraumatic spinal cord injury (infection, ischemia, metabolic, congenital, malignancy, radiation, surgery complications, or other diseases)
  • Have spinal cord injury from gunshot or penetrating injury
  • Have two or more noncontiguous spinal cord lesions
  • Have MRI or CT evidence of complete spinal cord transection
  • Depend on ventilation
  • Have conditions preventing clinical assessment of all four limbs (contracture, nerve injury, amputation)
  • Have uncontrolled seizures or recent seizure history (within 6 months for Chronic cohort, or 1 week after SCI for Subacute cohort)
  • Have metal implants in the head interfering with MRI
  • Be pregnant or breastfeeding
  • Have neurological conditions interfering with study assessments (multiple sclerosis, stroke, syringomyelia)
  • Have substance abuse history within 12 months
  • Have spinal instability or stenosis related to trauma
  • Have prior cell therapy into the central nervous system
  • Have severe neuropathic pain not controlled by medication
  • Have body mass index over 40
  • Received botulinum toxin injections in limbs within 6 months
  • Received 4-aminopyridine within 7 days before first dose
  • Prior treatment with protein tyrosine phosphatase sigma mimetic peptide
  • Intrathecal opioid use
  • Currently in another interventional clinical trial
  • Received non-permitted medication within 5.5 half-lives or 7 days before randomization
  • Receiving treatments to enhance neuroplasticity currently or within 4 weeks
  • Have implanted internal spinal cord stimulator
  • Currently receiving neuromuscular, vagal, or phrenic nerve stimulation
  • For Chronic cohort only: contraindications to MRI (pacemaker, metallic particles, baclofen pump, vascular clips, prosthetic valves, severe claustrophobia)
  • Malignancy within 5 years except some skin or breast/cervical cancers
  • Significant liver or kidney disease
  • Other diseases or injuries interfering with assessments
  • Other medical or social conditions making participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60611

Actively Recruiting

Loading map...

Research Team

C

Cara Casseday

CONTACT

N

NervGen Pharma

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here