NVG-291 in Spinal Cord Injury Subjects

NCT05965700 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NVG-291-201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries; Chronic Spinal Cord Injury; Subacute Spinal Cord Injury

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Electrophysiological

  MEP amplitudes (corticospinal contribution) in key target muscle groups

  12 weeks

Secondary Outcomes (8)

• 10mWT time

  12 weeks

• 9-HPT time

  12 weeks

• Dynamometry testing (pinch grip, Chronic cohort 1; hand grip, Subacute cohort 2)

  12 weeks

• Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test

  12 weeks

• Lower extremity motor score (LEMS)

  12 weeks

Study Arms (2)

NVG-291 for SC Injection

EXPERIMENTAL

NVG-291 administered by subcutaneous injection once daily for 12 weeks, with cetirizine pretreatment.

Drug: NVG-291

Placebo for SC Injection

PLACEBO COMPARATOR

Matching placebo administered by subcutaneous injection once daily for 12 weeks, with cetirizine pretreatment.

Drug: Placebo Injection

Interventions

NVG-291 DRUG

A once daily injection

NVG-291 for SC Injection

Placebo Injection DRUG

A once daily injection

Placebo for SC Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 spinal cord injury (SCI) resulting from acute physical trauma.
• Males and females.
• Age 18 to 75 years, inclusive.
• Cervical SCI, incomplete, with a neurological level of injury 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.
• Chronic Cohort 1 only: Must be able to volitionally initiate at least one step on one leg (without body weight support).
• Must have a Walking Index for Spinal Cord Injury II (WISCI II) score as follows:
• Chronic Cohort 1: Less than or equal to Level 14.
• Subacute Cohort 2: Less than or equal to Level 10.
• Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Prehension Ability score/hand grip strength as follows:
• Chronic Cohort 1:
• 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.
• Must have no more than one Prehension Ability grasp pattern score = 4 in the upper extremity satisfying the criterion above.
• Subacute Cohort 2:

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).
• SCI 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, or amputation.
• History of uncontrolled seizures, or:
• Chronic Cohort 1: Any seizure within the last 6 months.
• Subacute Cohort 2: Any seizure occurring 1 week or more after the SCI.
• Metal implant in the head that is likely to interfere with MRI analysis.
• Pregnant or breastfeeding.
• Any neurological condition that is considered to interfere with performance or likely 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 the initial trauma.
• Prior treatment with cell therapy delivered into the central nervous system (intrathecal or intraparenchymal).

Sponsors & Collaborators

• NervGen Pharma: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Hosseini SM, Stecina K, Nemati S, Wang RR, Zhang JV, Karimi-Abdolrezaee S. Circuit Reconstruction after Traumatic Spinal Cord Injury by Cellular and Pharmacological Approaches. J Neurosci. 2025 Aug 27;45(35):e0362252025. doi: 10.1523/JNEUROSCI.0362-25.2025.

  PMID: 40744729 DERIVED

Related Links

• Connect SCI Study Website
• SCI Trials Finder Website

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Randall Kaye, M.D.

  NervGen Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 28, 2023
• Study Start: August 8, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 21, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)