NVG-291 in Spinal Cord Injury Subjects

March 19, 2024 updated by: NervGen Pharma

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Shirley Ryan AbilityLab
        • Principal Investigator:
          • Monica A Perez, PT, PhD
        • Principal Investigator:
          • David Chen, MD
        • Contact:
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 SCI resulting from acute physical trauma.

Males and females

Age 18 - 75 years, inclusive.

Cervical SCI, incomplete, with a neurological level of injury being at C7 or higher.

Had incomplete cervical SCI within the period from 1 year to 10 years inclusive (Chronic cohort 1) OR within 10 days to 49 days inclusive (Subacute cohort 2) at time of randomization.

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:

  1. For Chronic cohort 1: Less than or equal to Level 14.
  2. For Subacute cohort 2: Less than or equal to Level 8.

GRASSP Prehension Ability score

For Chronic cohort 1:

i. 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. ii. Must have no more than one Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i

For Subacute cohort 2:

i. Must have a score of 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment in at least one upper extremity. ii. Must have no more than one Prehension Ability grasp patterns score = 3 in the upper extremity satisfying criterion i. iii. Must not have a Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i.

Must be fluent in English.

Subjects 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, or other disease process).

Spinal cord injury due to gunshot wound or penetrating injury.

Two or more (noncontiguous) spinal cord lesions.

MRI 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, amputation.

History of seizures (febrile seizures allowed).

Metal implant in the head.

History of traumatic brain injury without recovery.

Any neurological condition that may interfere with performance or confound assessment, such as multiple sclerosis, stroke, or 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 initial trauma.

Prior treatment with cell therapy delivered into the CNS (intrathecal or intraparenchymal).

Severe neuropathic pain inadequately controlled by medication.

Body mass index (BMI) > 40 (body weight in kilograms divided by height in meters squared).

Received botulinum toxin injection(s) in an upper or lower extremity muscle in the prior 6 months.

Received 4-aminopyridine within 14 days of screening.

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 to participate in this study or within 4 weeks of randomization, whichever is longer.

Any implanted internal spinal cord stimulator.

Currently receiving neuromuscular stimulation.

Currently receiving vagal nerve stimulation.

Any contraindication to undergo MRI studies such as:

  1. History of a cardiac pacemaker or pacemaker wires, OR
  2. Metallic particles in the body, OR
  3. Baclofen pump, OR
  4. Vascular clips in the head, OR
  5. Prosthetic heart valves, OR
  6. 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.

Severe renal insufficiency, as defined by eGFR < 30 mL/min/1.73m2.

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
Intervention / Treatment
Experimental: NVG-291 for Injection
Injected under the skin (subcutaneous).
Drug: NVG-291
A once daily injection
Placebo Comparator: Placebo
Injected under the skin (subcutaneous).
Drug: NVG-291
A once daily injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrophysiological
Time Frame: 16 weeks
MEP amplitudes (corticospinal contribution)
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10mWT time
Time Frame: 16 weeks
Walking speed
16 weeks
9-HPT time
Time Frame: 16 weeks
Upper extremity dexterity
16 weeks
Pinch dynamometry
Time Frame: 16 weeks
Recorded force
16 weeks
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test
Time Frame: 16 weeks
Hand function Max Score 116 points (higher is better)
16 weeks
Lower extremity motor score (LEMS)
Time Frame: 16 weeks
Lower extremity Max Score 50 points (25 points per side - higher is better)
16 weeks
Upper extremity motor score (UEMS)
Time Frame: 16 weeks
Upper extremity Max Score 50 points (25 points per side - higher is better)
16 weeks

Collaborators and Investigators

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

Sponsor

NervGen Pharma

Investigators

  • Study Director: Daniel Mikol, M.D. Ph.D., NervGen Pharma

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)

August 8, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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