Chronic Spinal Cord InjuryPhase 3RESTORENCT07799532
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
A Phase 3 study testing NVG-291 in people with Chronic Spinal Cord Injury, run by NervGen Pharma at 23 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spinal Cord Injury
- What is being tested?
- NVG-291
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 28 Sep 2026to 14 Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Nontraumatic spinal cord injury, penetrating spinal cord injury, multiple noncontiguous spinal cord lesions, or anatomically complete spinal cord transection.
- Ventilatory dependence, defined as invasive mechanical ventilation via tracheostomy, noninvasive ventilation for chronic respiratory failure, or diaphragmatic or phrenic nerve pacing. Continuous or automatic positive airway pressure (CPAP/APAP) used solely for obstructive sleep apnea is not exclusionary.
- 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.
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- 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.
- Malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer or cervical or breast carcinoma in situ.
- Clinically significant hepatic disease, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × upper limit of normal, or severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²).
- Any disease, injury, medical condition, social condition, or behavioral condition that could interfere with study participation, study assessments, interpretation of results, or compliance with study requirements, in the opinion of the investigator.
Trial locations and contacts
23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 2 countries
United States21 sites, 21 recruiting
- Not yet recruiting
NervGen NVG-291-301 Site#101
Atlanta, Georgia, 30309
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#104
Birmingham, Alabama, 35294
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site # 121
Boston, Massachusetts, 02138
778-731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#115
Camden, New Jersey, 08103
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#113
Charleston, South Carolina, 29425
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#108
Charlotte, North Carolina, 28203
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site# 119
Cleveland, Ohio, 44111
778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#109
Downey, California, 90242
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#106
Englewood, Colorado, 80113
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#110
Houston, Texas, 77030
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Recruiting
International Neurorehabilitation Institute
Lutherville, Maryland, 21093
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#107
Miami, Florida, 33136
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#102
Milwaukee, Wisconsin, 53226
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#117
Paramus, New Jersey, 07652
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site# 118
Pheonix, Arizona, 85013
778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#116
Philadelphia, Pennsylvania, 19146
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site# 120
Richmond, Virginia, 23298
778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#111
Rochester, Minnesota, 55905
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Recruiting
New England Institue for Clinical Research
Stamford, Connecticut, 06905
contact@neicr.com, (203) 914-1903, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#112
Washington D.C., District of Columbia, 20010
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#114
West Orange, New Jersey, 07052
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
Canada2 sites, 2 recruiting
- Not yet recruiting
NervGen NVG-291-301 Site# 202
Edmonton, Albert, T6G 2B7
778 731-1711, restorestudy@nervgen.com
- Not yet recruiting
NervGen NVG-291-301 Site#201
Vancouver, British Columbia, V5Z 1M9
restorestudy@nervgen.com, 778 731-1711, restorestudy@nervgen.com
About this study
Official title: A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury - A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Trial (RESTORE)
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.
Read more
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.
Read the detailed description
NVG-291 is an investigational peptide therapeutic designed to promote nervous system repair by modulating pathways that may inhibit neural regeneration after spinal cord injury. Chronic cervical motor-incomplete spinal cord injury is associated with persistent impairments in upper-extremity function, mobility, independence, and quality of life, and there are currently no approved pharmacologic therapies specifically intended to promote neurological repair in this population. Previous nonclinical studies and an earlier randomized clinical study of NVG-291 provided evidence supporting further evaluation of its potential to improve neurological connectivity and functional recovery in individuals with chronic cervical motor incomplete spinal cord injury.
RESTORE (NVG-291-301) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of NVG-291 in adults with chronic cervical motor incomplete spinal cord injury. Approximately 150 participants will be enrolled at up to 60 sites in the United States and Canada and randomized in a 1:1 ratio to receive either NVG-291 or placebo. Randomization will be stratified by country and baseline injury severity category.
Participants will receive once-daily subcutaneous administration of study treatment for 12 weeks, followed by a 4-week noninterventional follow-up period. The study is designed to assess treatment effects after completion of the dosing period and to evaluate whether any observed functional changes persist following treatment discontinuation. Primary analysis will be performed at Week 12, with follow-up through Week 16.
In addition to efficacy and safety assessments, the study will characterize the population pharmacokinetics of NVG-291 in a subset of participants receiving NVG-291, and will evaluate patient-reported outcomes, functional measures, quality-of-life assessments, and exploratory measures intended to further characterize the potential effects of NVG-291 on recovery following spinal cord injury. An optional open-label extension study may be offered following completion of the main study to provide access to NVG-291 for participants originally assigned to placebo.
- Conditions
- Chronic Spinal Cord Injury
- Being tested
- NVG-291, Placebo
- Keywords
- Chronic Spinal Cord Injury, Cervical Spinal Cord Injury, Tetraplegia
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVG-291Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Patient Global Impression of Change (PGIC) at Week 12. The PGIC is a single-item, patient-reported measure of perception of change in condition, scored on a 7-point scale from 1 (very much worse) to 7 (very much improved). Higher scores indicate greater improvement.
Measured: Week 12
Efficacy of NVG-291 as measured by change at Week 12 in Clinician Global Impression of Change (CGIC)
The CGIC is a single-item, clinician-reported measure of change in condition, scored on a 7-point scale from 1 (very much worse) to 7 (very much improved). Higher scores indicate greater improvement.
Measured: Week 12
Efficacy of NVG-291 as measured by change from baseline in Spinal Cord Independence Measure Version III (SCIM-III)
Change from baseline to Week 12 in the Spinal Cord Independence Measure, Version III (SCIM-III) total score. The SCIM-III total score ranges from 0 to 100. Higher scores indicate greater functional independence.
Measured: Baseline to Week 12
Efficacy of NVG-291 as measured by change from baseline in Modified Ashworth Scale (MAS) score
Change from baseline to Week 12 in the Modified Ashworth Scale (MAS) total score, the sum of scores for the quadriceps femoris, hamstrings, and soleus assessed bilaterally. Total scores range from 0 to 30. Higher scores indicate more severe spasticity.
Measured: Baseline to Week 12
Participant-perceived meaningfulness of change assessed by the patient-reported outcome (PRO) Qualitative Interview
Patient-reported perception of change from baseline at Week 12, assessed by a semi-structured qualitative interview conducted within 14 days after the Week 12 visit. The interview is not a scored scale and has no minimum or maximum value. Transcripts are coded against a prespecified analysis framework, and results will be reported as the number and percentage of participants reporting meaningful improvement in each prespecified concept.
Measured: Within 14 days after the Week 12 visit
Efficacy of NVG-291 as measured by change from baseline in 10 Meter Walk Test (10mWT)
Change from baseline to Week 12 in walking velocity (meters/second) measured by the 10 Meter Walk Test (10mWT). Higher walking velocity indicates better performance.
Measured: Baseline to Week 12
Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Total Score
Change from baseline to Week 12 in the combined GRASSP Total score, the sum of the strength, sensibility, and prehension domain scores for the right and the left hand. The combined GRASSP Total score ranges from 0 to 188. Higher scores indicate better upper-extremity function.
Measured: Baseline to Week 12
Efficacy of NVG-291 as measured by change from baseline in Clinician Global Impression of Severity (CGIS)
Change from baseline to Week 12 in the Clinician Global Impression of Severity (CGIS) score. The CGIS is a single-item, clinician-rated measure of overall severity, scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity.
Measured: Baseline to Week 12
Efficacy of NVG-291 as measured by change from baseline in Patient Global Impression of Severity (PGIS)
Change from baseline to Week 12 in the Patient Global Impression of Severity (PGIS) score. The PGIS is a single-item, participant-rated measure of overall severity, scored on a 5-point scale from 1 (none) to 5 (very severe). Higher scores indicate greater severity.
Measured: Baseline to Week 12
Safety and tolerability of NVG-291 as assessed by the incidence of adverse events (AEs)
Incidence of AEs.
Measured: Informed consent through Week 16
Safety and tolerability of NVG-291 as assessed by the incidence of serious adverse events (SAEs)
Incidence of SAEs.
Measured: Informed consent through Week 16
Safety and tolerability of NVG-291 as assessed by the number of participants with clinically significant laboratory abnormalities
Number of participants with clinically significant abnormalities in clinical laboratory assessments.
Measured: Baseline through Week 16
Safety and tolerability of NVG-291 as assessed by change from baseline in systolic blood pressure
Change from baseline in systolic blood pressure (mmHg).
Measured: Baseline through Week 16
Safety and tolerability of NVG-291 as assessed by change from baseline in diastolic blood pressure
Change from baseline in diastolic blood pressure (mmHg).
Measured: Baseline through Week 16
Safety and tolerability of NVG-291 as assessed by change from baseline in heart rate
Change from baseline in heart rate (beats/minute).
Measured: Baseline through Week 16
Safety and tolerability of NVG-291 as assessed by change from screening in body weight
Change from screening in body weight (kg).
Measured: Screening through Week 16
Safety and tolerability of NVG-291 as assessed by change from baseline in body temperature
Change from baseline in body temperature (°C).
Measured: Baseline through Week 16
Safety and tolerability of NVG-291 as assessed by the number of participants with clinically significant electrocardiogram abnormalities
Number of participants with clinically significant electrocardiogram (ECG) abnormalities.
Measured: Baseline through Week 16
Pharmacokinetics of NVG-291 as measured by plasma NVG-291 concentration
Plasma NVG-291 concentration (ng/mL) in participants randomized to NVG-291 who are included in the pharmacokinetic subset. Samples are collected pre-dose, 30 minutes post-dose, and 3 hours post-dose at each specified visit, to support a population pharmacokinetic (PopPK) analysis.
Measured: Day 1 Through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start28 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completion14 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NervGen Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799532
- Sponsor's protocol ID
- NVG-291-301
- Acronym
- RESTORE
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No