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Spinal Cord InjuriesPhase 1/2NCT05965700

NVG-291 in Spinal Cord Injury Subjects

A Phase 1/2 study testing NVG-291 in people with Spinal Cord Injuries and Chronic Spinal Cord Injury, run by NervGen Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
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
24 participants
Where
1 siteUnited States
Study dates
8 Aug 2023to 21 Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
NVG-291, Placebo Injection
Keywords
Spinal Cord Injury
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NVG-291Drug

    A once daily injection

  • Placebo InjectionDrug

    A once daily injection

Study groups in NCT05965700
Study groupRoleWhat they receive
NVG-291 for SC InjectionExperimentalNVG-291 administered by subcutaneous injection once daily for 12 weeks, with cetirizine pretreatment.
Receives: Drug: NVG-291
Placebo for SC InjectionPlacebo comparatorMatching placebo administered by subcutaneous injection once daily for 12 weeks, with cetirizine pretreatment.
Receives: Drug: Placebo Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electrophysiological

    MEP amplitudes (corticospinal contribution) in key target muscle groups

    Measured: 12 weeks

Secondary outcomes (8)

  1. 10mWT time

    Walking speed

    Measured: 12 weeks

  2. 9-HPT time

    Upper extremity dexterity

    Measured: 12 weeks

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

    Recorded force

    Measured: 12 weeks

  4. Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test

    Hand function Max Score 116 points

    Measured: 12 weeks

  5. Lower extremity motor score (LEMS)

    Lower extremity Max Score 50 points

    Measured: 12 weeks

  6. Upper extremity motor score (UEMS)

    Upper extremity Max Score 50 points

    Measured: 12 weeks

  7. Incidences of Treatment Emergent Adverse Events (Safety and Tolerability)

    incidences of treatment emergent adverse events

    Measured: 16 Weeks

  8. Plasma Concentration of Study Drug

    initial and steady state predose and peak plasma drug concentrations

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start8 Aug 2023
  3. Primary completion31 Dec 2025
  4. Study completion21 Jan 2026

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05965700
Sponsor's protocol ID
NVG-291-201
Status last verified
Nov 2026
First submitted
16 Jul 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40744729

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NVG-291 in people with Spinal Cord Injuries and Chronic Spinal Cord Injury, run by NervGen Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrophysiological (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05965700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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