A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury

NCT07799532 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NVG-291-301
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 18

Brief Summary

The goal of this clinical trial is to learn if NVG-291 can improve function in adults with chronic cervical motor-incomplete spinal cord injury. It will also learn about the safety of NVG-291. The main questions it aims to answer are:

• Does NVG-291 improve hand function and daily activities?
• What side effects do participants have when taking NVG-291? Researchers will compare NVG-291 to a placebo (a look-alike substance that does not contain NVG-291) to see if NVG-291 improves function in adults with chronic cervical motor-incomplete spinal cord injury. Participants will:
• Take NVG-291 or a placebo by injection under the skin (subcutaneous) once daily for 12 weeks.
• Attend clinic visits for checkups and safety tests.
• Complete tests and questionnaires about hand function, walking, daily activities, and quality of life.
• Take part in an interview about changes in their condition, within 14 days after the Week 12 visit.

Conditions

Chronic Spinal Cord Injury

Keywords

Chronic Spinal Cord Injury; Cervical Spinal Cord Injury; Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Efficacy of NVG-291 as measured by change from baseline in combined Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension (QtP) score

  Change from baseline to Week 12 in the combined GRASSP QtP score. The combined GRASSP QtP score is the sum of four Prehension Performance task scores for the right and the left hand and ranges from 0 to 40. A higher score on GRASSP QtP indicates improved prehension performance.

  Baseline to Week 12

Secondary Outcomes (19)

• Efficacy of NVG-291 as measured by change at Week 12 in Patient Global Impression of Change (PGIC)

  Week 12

• Efficacy of NVG-291 as measured by change at Week 12 in Clinician Global Impression of Change (CGIC)

  Week 12

• Efficacy of NVG-291 as measured by change from baseline in Spinal Cord Independence Measure Version III (SCIM-III)

  Baseline to Week 12

• Efficacy of NVG-291 as measured by change from baseline in Modified Ashworth Scale (MAS) score

  Baseline to Week 12

• Participant-perceived meaningfulness of change assessed by the patient-reported outcome (PRO) Qualitative Interview

  Within 14 days after the Week 12 visit

Other Outcomes (4)

• Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Quantitative Prehension (QtP) score at Week 16

  Baseline to Week 16

• Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Total Score at Week 16

  Baseline to Week 16

• Efficacy of NVG-291 as measured by change from baseline in SCI-QOL Bladder Management Short Form score

  Baseline to Week 12

Study Arms (2)

NVG-291 Arm

EXPERIMENTAL

Participants will receive NVG-291 administered once daily by subcutaneous injection for 12 weeks during the double-blind treatment period. Randomization will occur in a 1:1 ratio and will be stratified by country (United States or Canada) and baseline American Spinal Injury Association (ASIA) Impairment Scale category (C or D).

Drug: NVG-291

Placebo Arm

PLACEBO COMPARATOR

Participants will receive placebo administered once daily by subcutaneous injection for 12 weeks during the double-blind treatment period. Randomization will occur in a 1:1 ratio and will be stratified by country (United States or Canada) and baseline American Spinal Injury Association (ASIA) Impairment Scale category (C or D).

Drug: Placebo

Interventions

NVG-291 DRUG

NVG-291 is an investigational peptide therapeutic administered by subcutaneous injection. Participants randomized to the experimental arm will receive NVG-291 once daily for 12 weeks. NVG-291 is designed to promote nervous system repair and functional recovery following chronic spinal cord injury.

NVG-291 Arm

Placebo DRUG

Matching placebo is supplied as a sterile lyophilized formulation matching NVG-291 in appearance and route of administration. Participants randomized to the placebo arm will receive placebo once daily by subcutaneous injection for 12 weeks.

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent prior to any study-specific procedures.
• Be 18 to 75 years of age, inclusive.
• Have chronic cervical spinal cord injury resulting from acute traumatic injury occurring 1 to 10 years prior to randomization.
• Have motor-incomplete cervical spinal cord injury as determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) assessment at screening, meeting all of the following: American Spinal Injury Association (ASIA) Impairment Scale grade C or D; motor level at C7 or rostral on both the right and the left side; and a muscle grade of 1 or greater on ISNCSCI manual muscle testing in at least one lower-extremity key muscle function (L2 to S1) on either side.
• Have documented traumatic spinal cord injury confirmed by historical and/or current magnetic resonance imaging (MRI) or computed tomography (CT).
• Have a Walking Index for Spinal Cord Injury II (WISCI II) score of 0 to 14, inclusive.
• Have a score of at least 2 on at least one GRASSP Prehension Ability grasp pattern (cylindrical grasp, lateral key pinch, or tip-to-tip pinch) in at least one upper extremity, no more than one grasp-pattern score of 4 in the qualifying upper extremity, and a combined (bilateral) GRASSP Quantitative Prehension score no greater than 34, of a possible 40, across the sum of the four Prehension Performance task scores for the right and left hand.
• Be willing and able to comply with study visits, assessments, study procedures, and study drug administration requirements.
• Female participants of childbearing potential and male participants must agree to use protocol-specified contraception during study participation.

You may not qualify if:

• Nontraumatic spinal cord injury, penetrating spinal cord injury, multiple noncontiguous spinal cord lesions, or anatomically complete spinal cord transection.
• Any condition preventing adequate assessment of all four extremities.
• Any neurological condition that could interfere with study assessments or interpretation of results, including multiple sclerosis, stroke, amyotrophic lateral sclerosis, dementia, or progressive syringomyelia.
• History of uncontrolled seizures or any seizure within 6 months prior to screening.
• Pregnant or breastfeeding.
• History of substance abuse within 12 months prior to screening.
• Evidence of spinal instability, persistent spinal stenosis, or spinal cord compression related to the original injury.
• Prior treatment with central nervous system gene therapy. Prior treatment with a protein tyrosine phosphatase sigma (PTPσ) mimetic peptide. Stem cell or cell therapy within 12 months prior to screening.
• Severe neuropathic pain inadequately controlled by medication.
• Body mass index (BMI) \>40 kg/m².
• Known hypersensitivity to cetirizine, mannitol, trehalose, or polysorbate 80.
• Receipt of botulinum toxin injection within 6 months prior to screening or 4-aminopyridine within 7 days prior to first dose. Current intrathecal opioid use.
• Current participation in another interventional clinical trial or prior exposure to NVG-291.
• Receipt of prohibited medications or therapies intended to enhance neuroplasticity within protocol-defined restricted periods.
• Presence of an implanted neurostimulation or brain-computer interface device, or current neurostimulation therapy, including spinal cord stimulation, neuromuscular stimulation, vagal nerve stimulation, or phrenic nerve stimulation.

Sponsors & Collaborators

• NervGen Pharma: lead

Study Sites (18)

NervGen NVG-291-301 Site#104

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#109

Downey, California, 90242, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#106

Englewood, Colorado, 80113, United States

NOT YET RECRUITING

New England Institue for Clinical Research

Stamford, Connecticut, 06905, United States

RECRUITING

NervGen NVG-291-301 Site#112

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#107

Miami, Florida, 33136, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#101

Atlanta, Georgia, 30309, United States

NOT YET RECRUITING

International Neurorehabilitation Institute

Lutherville, Maryland, 21093, United States

RECRUITING

NervGen NVG-291-301 Site#111

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#115

Camden, New Jersey, 08103, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#117

Paramus, New Jersey, 07652, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#114

West Orange, New Jersey, 07052, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#108

Charlotte, North Carolina, 28203, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#116

Philadelphia, Pennsylvania, 19146, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#113

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#110

Houston, Texas, 77030, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#102

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

NervGen NVG-291-301 Site#201

Vancouver, British Columbia, V5Z 1M9, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

NervGen Study Team

CONTACT

778 731-1711; restorestudy@nervgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All subjects, investigators, and study personnel involved in the conduct of the study, including data management, will be blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 2, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (17)