A Phase 3 interventional study of NVG-291 and Placebo in Chronic Spinal Cord Injury, sponsored by NervGen Pharma. Recruiting at 23 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by NervGen Pharma · Phase 3, Interventional, and Treatment
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:
Participants will:
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.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 150 is above the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →NervGen Pharma is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12
Safety and tolerability of NVG-291 as assessed by the incidence of adverse events (AEs)
Incidence of AEs.
Time frame: Informed consent through Week 16
Safety and tolerability of NVG-291 as assessed by the incidence of serious adverse events (SAEs)
Incidence of SAEs.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 1 Through Week 12
Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Quantitative Prehension (QtP) score at Week 16
Change from baseline to Week 16 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.
Time frame: Baseline to Week 16
Efficacy of NVG-291 as measured by change from baseline in combined GRASSP Total Score at Week 16
Change from baseline to Week 16 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.
Time frame: Baseline to Week 16
Efficacy of NVG-291 as measured by change from baseline in SCI-QOL Bladder Management Short Form score
Change from baseline to Week 12 in the Spinal Cord Injury - Quality of Life (SCI-QOL) Bladder Management Difficulties Short Form score. Scores are reported as T-scores calibrated to the SCI reference population (mean 50, standard deviation 10), with a possible range of 40.9 to 81.6 for this short form. Higher scores indicate greater bladder management difficulties.
Time frame: Baseline to Week 12
Efficacy of NVG-291 as measured by change from baseline in EQ-5D-5L score
Change from baseline to Week 12 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, reported as the EQ Visual Analogue Scale (EQ VAS) score. The EQ VAS records self-rated health on a scale of 0 to 100, where 0 is the worst imaginable health state and 100 is the best imaginable health state. Higher scores indicate better health.
Time frame: Baseline to Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2027, 10 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: NVG-291
NervGen Pharma