NVG-291 in Spinal Cord Injury Subjects

November 2, 2026 updated by: NervGen Pharma

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To evaluate the effect of NVG-291 on descending connectivity in subjects with subacute and chronic SCI (20 subjects per Cohort and results will be analyzed separately) using objective electrophysiological measures, in addition to clinical assessments. To evaluate safety and tolerability of NVG-291 in a SCI population, as measured by clinical assessments (Physical Examination, Vital Signs, ECG, etc.) as well as clinical laboratory measures. NOTE: Enrollment of the chronic cohort has been completed; approximately 20 individuals will be enrolled in the subacute group. For more information about the trial please visit www.connectscistudy.com.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan AbilityLab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:
  • Must have some voluntary (nonzero) force measured by grip dynamometry in at least one upper extremity.
  • Must have no more than one Prehension Ability grasp pattern score = 3 in at least one upper extremity.
  • Must not have a Prehension Ability grasp pattern score = 4 in the upper extremity satisfying the criterion above.
  • Presence of Motor Evoked Potentials (MEPs):
  • Chronic Cohort 1: In two specific target muscle groups.
  • Subacute Cohort 2: In one specific target muscle group.
  • Must be fluent in English.
  • Must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.

Exclusion Criteria:

  • 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).
  • Severe neuropathic pain inadequately controlled by medication.
  • Body mass index (BMI) > 40 kg/m2.
  • Received botulinum toxin injection(s) in an upper or lower extremity muscle in the prior 6 months.
  • Received 4-aminopyridine within 7 days of first dose.
  • Prior treatment with a protein tyrosine phosphatase sigma (PTPσ) mimetic peptide.
  • Intrathecal opioid use.
  • Currently participating in an interventional clinical trial.
  • Received a non-permitted medication within 5.5 half-lives or 7 days, whichever is longer, prior to randomization.
  • Receiving any treatment intended to enhance neuroplasticity (e.g., electrical stimulation, acute intermittent hypoxia) at the time of consent or within 4 weeks of randomization, whichever is longer.
  • Any implanted internal spinal cord stimulator.
  • Currently receiving neuromuscular stimulation.
  • Currently receiving vagal or phrenic nerve stimulation.
  • Chronic Cohort 1 only: Any contraindication to baseline and on-study MRIs, such as:
  • History of a cardiac pacemaker or pacemaker wires.
  • Ferromagnetic metallic particles in the body.
  • Baclofen pump.
  • Vascular clips in the head.
  • Prosthetic heart valves.
  • Severe claustrophobia impeding ability to participate in an imaging study.
  • Malignancy within 5 years prior to screening, except for non-melanoma skin cancers or cervical or breast ductal carcinoma in situ.
  • History of medically significant hepatic disease or evidence of impaired liver function based on initial laboratory testing.
  • Severe renal insufficiency, defined as eGFR < 30 mL/min/1.73m2.
  • Any disease, concomitant injury (such as significant traumatic brain injury), or condition that could interfere with the performance or interpretation of the protocol-specified assessments, in the opinion of the investigator.
  • Any other social or medical condition (e.g., uncontrolled diabetes, unstable hypertension) which, in the opinion of the investigator, would make the subject unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NVG-291 for SC Injection

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

A once daily injection
Placebo Comparator: Placebo for SC Injection

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

A once daily injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Electrophysiological
Time Frame: 12 weeks

MEP amplitudes (corticospinal contribution) in key target muscle groups
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
10mWT time
Time Frame: 12 weeks

Walking speed
12 weeks
9-HPT time
Time Frame: 12 weeks

Upper extremity dexterity
12 weeks
Dynamometry testing (pinch grip, Chronic cohort 1; hand grip, Subacute cohort 2)
Time Frame: 12 weeks

Recorded force
12 weeks
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test
Time Frame: 12 weeks

Hand function Max Score 116 points
12 weeks
Lower extremity motor score (LEMS)
Time Frame: 12 weeks

Lower extremity Max Score 50 points
12 weeks
Upper extremity motor score (UEMS)
Time Frame: 12 weeks

Upper extremity Max Score 50 points
12 weeks
Incidences of Treatment Emergent Adverse Events (Safety and Tolerability)
Time Frame: 16 Weeks

incidences of treatment emergent adverse events
16 Weeks
Plasma Concentration of Study Drug
Time Frame: 12 Weeks

initial and steady state predose and peak plasma drug concentrations
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NervGen Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Randall Kaye, M.D., NervGen Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NVG-291-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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